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Study · Randomized controlled trial · 2012

20 results

Multiple once-daily subcutaneous doses of pasireotide were well tolerated in healthy male volunteers: a randomized, double-blind, placebo-controlled, cross-over, Phase I study.

Beglinger C, Hu K, Wang Y, Bouillaud E, Darstein C, Wang Y, Mohideen P

Endocrine21 Apr 2012Cited by 15 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study20

20 results from studies that gave the peptide. 20 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In healthy men, pasireotide 600 μg sc was associated with higher preprandial glucose than placebo.

    In plain wordsIn healthy men, pasireotide 600 μg was linked to higher blood sugar before meals than placebo.

    Outcome
    IncreasePreprandial glucose versus placebo
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Pasireotide 600 μg sc was associated with pre- and post-prandial elevations in glucose levels relative to placebo; however, this effect was less pronounced on day 14 compared with day 1.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  2. 02HumanRandomized controlled trialSafety outcome

    In healthy men, pasireotide 600 μg sc was associated with higher postprandial glucose than placebo.

    In plain wordsIn healthy men, pasireotide 600 μg was linked to higher blood sugar after meals than placebo.

    Outcome
    IncreasePostprandial glucose versus placebo
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Pasireotide 600 μg sc was associated with pre- and post-prandial elevations in glucose levels relative to placebo; however, this effect was less pronounced on day 14 compared with day 1.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  3. 03HumanNon-randomized trialSafety outcome

    In healthy men receiving pasireotide, 18 reported drug-related injection-site reactions, mostly mild or moderate.

    In plain wordsIn healthy men receiving pasireotide, 18 reported injection-site reactions, mostly mild or moderate.

    Outcome
    Not applicableInjection-site reactions
    Study

    n: not reported in source

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    50, 200, or 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Measurements

    Participants with drug-related injection-site reactions
    18 participants
    pasireotide 50, 200 or 600 μg sc qd for 14 days

    Source sentences

    Summary
    The most frequently reported drug-related adverse events were injection-site reactions (n = 18), diarrhea (n = 14) and nausea (n = 10), which were mostly mild or moderate in intensity.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  4. 04HumanNon-randomized trialSafety outcome

    In healthy men receiving pasireotide, 14 reported drug-related diarrhea, mostly mild or moderate.

    In plain wordsIn healthy men receiving pasireotide, 14 reported diarrhea, mostly mild or moderate.

    Outcome
    Not applicableDiarrhea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    50, 200, or 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Measurements

    Participants with drug-related diarrhea
    14 participants
    pasireotide 50, 200 or 600 μg sc qd for 14 days

    Source sentences

    Summary
    The most frequently reported drug-related adverse events were injection-site reactions (n = 18), diarrhea (n = 14) and nausea (n = 10), which were mostly mild or moderate in intensity.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  5. 05HumanNon-randomized trialSafety outcome

    In healthy men receiving pasireotide, 10 reported drug-related nausea, mostly mild or moderate.

    In plain wordsIn healthy men receiving pasireotide, 10 reported nausea, mostly mild or moderate.

    Outcome
    Not applicableNausea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    50, 200, or 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Measurements

    Participants with drug-related nausea
    10 participants
    pasireotide 50, 200 or 600 μg sc qd for 14 days

    Source sentences

    Summary
    The most frequently reported drug-related adverse events were injection-site reactions (n = 18), diarrhea (n = 14) and nausea (n = 10), which were mostly mild or moderate in intensity.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  6. 06HumanNon-randomized trialSafety outcome

    In healthy men receiving pasireotide 600 μg, glucose elevations were less pronounced on day 14 than day 1.

    In plain wordsIn healthy men, pasireotide-related blood sugar elevations were smaller on day 14 than day 1.

    Outcome
    DecreaseGlucose effect attenuation
    Study

    n: not reported in source

    Comparator
    day 1
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Pasireotide 600 μg sc was associated with pre- and post-prandial elevations in glucose levels relative to placebo; however, this effect was less pronounced on day 14 compared with day 1.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  7. 07HumanNon-randomized trialPharmacokinetics

    In healthy men, pasireotide appeared to reach PK steady state after 3 days of dosing.

    In plain wordsIn healthy men, pasireotide appeared to reach stable exposure after three days of dosing.

    Outcome
    Not applicableTime to steady state
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    50, 200, or 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Measurements

    Time to PK steady state
    3 days
    pasireotide sc qd, healthy men

    Source sentences

    Summary
    PK steady state appeared to be achieved after 3 days of dosing and PK exposures had a moderate accumulation of 20-40 % across doses.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  8. 08HumanNon-randomized trialPharmacokinetics

    In healthy men, pasireotide PK exposure accumulated by 20-40 % across doses.

    In plain wordsIn healthy men, repeated pasireotide dosing increased exposure by 20-40 %.

    Outcome
    IncreaseAccumulation
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    50, 200, or 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Measurements

    Accumulation
    20 to 40%
    pasireotide sc qd across doses

    Source sentences

    Summary
    PK steady state appeared to be achieved after 3 days of dosing and PK exposures had a moderate accumulation of 20-40 % across doses.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  9. 09HumanNon-randomized trialPharmacokinetics

    In healthy men, pasireotide steady-state T(max,ss) was 0.25-0.5 h.

    In plain wordsIn healthy men, pasireotide reached peak levels in 0.25-0.5 h at steady state.

    Outcome
    Not applicableAbsorption time
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    50, 200, or 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Measurements

    Tmax,ss
    0.25 to 0.5 h
    pasireotide sc qd steady state

    Source sentences

    Summary
    Pasireotide demonstrated fast absorption (T(max,ss): 0.25-0.5 h)
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  10. 10HumanNon-randomized trialPharmacokinetics

    In healthy men, pasireotide steady-state CL/F(ss) was 8.10-9.03 L/h.

    In plain wordsIn healthy men, pasireotide clearance was 8.10-9.03 L/h at steady state.

    Outcome
    Not applicableClearance
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    50, 200, or 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Measurements

    CL/F(ss)
    8.1 to 9.03 L/h
    pasireotide sc qd steady state

    Source sentences

    Summary
    low clearance (CL/F(ss): 8.10-9.03 L/h)
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  11. 11HumanNon-randomized trialPharmacokinetics

    In healthy men, pasireotide effective half-life averaged approximately 12 h, ranging from 9.7 to 13.1 h across doses.

    In plain wordsIn healthy men, pasireotide effective half-life averaged about 12 hours.

    Outcome
    Not applicableEffective half-life
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    50, 200, or 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Measurements

    Effective half-life (mean)
    ≈ 12 h
    pasireotide sc qd
    Effective half-life, mean by dose
    9.7 to 13.1 h
    50, 200 and 600 μg sc qd

    Source sentences

    Summary
    long effective half-life (T(½,eff): ~12 h, on average between 9.7 and 13.1 h for 50, 200, and 600 μg sc qd)
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  12. 12HumanNon-randomized trialPharmacokinetics

    In healthy men, pasireotide steady-state V(z)/F(ss) was 251-1,091 L.

    In plain wordsIn healthy men, pasireotide distribution volume was 251-1,091 L at steady state.

    Outcome
    Not applicableDistribution volume
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    50, 200, or 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Measurements

    Vz/F(ss)
    251 to 1091 L
    pasireotide sc qd steady state

    Source sentences

    Summary
    and large volume of distribution (V(z)/F(ss): 251-1,091 L) at steady state.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  13. 13HumanNon-randomized trialPharmacokinetics

    In healthy men, pasireotide C(max,ss) was dose proportional.

    In plain wordsIn healthy men, pasireotide peak steady-state concentration increased in proportion to dose.

    Outcome
    IncreaseC(max,ss) dose proportionality
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    50, 200, or 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Dose proportionality was confirmed for C(max,ss); other PK parameters (C(max), AUC(0-24 h) and AUC(tau)) were approximately dose proportional.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  14. 14HumanNon-randomized trialPharmacokinetics

    In healthy men, pasireotide C(max) was approximately dose proportional.

    In plain wordsIn healthy men, pasireotide peak concentration increased approximately in proportion to dose.

    Outcome
    IncreaseC(max) dose proportionality
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    50, 200, or 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Dose proportionality was confirmed for C(max,ss); other PK parameters (C(max), AUC(0-24 h) and AUC(tau)) were approximately dose proportional.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  15. 15HumanNon-randomized trialPharmacokinetics

    In healthy men, pasireotide AUC(0-24 h) was approximately dose proportional.

    In plain wordsIn healthy men, pasireotide daily exposure increased approximately in proportion to dose.

    Outcome
    IncreaseAUC(0-24 h) dose proportionality
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    50, 200, or 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Dose proportionality was confirmed for C(max,ss); other PK parameters (C(max), AUC(0-24 h) and AUC(tau)) were approximately dose proportional.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  16. 16HumanNon-randomized trialPharmacokinetics

    In healthy men, pasireotide AUC(tau) was approximately dose proportional.

    In plain wordsIn healthy men, pasireotide exposure over the dosing interval increased approximately in proportion to dose.

    Outcome
    IncreaseAUC(tau) dose proportionality
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    50, 200, or 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Dose proportionality was confirmed for C(max,ss); other PK parameters (C(max), AUC(0-24 h) and AUC(tau)) were approximately dose proportional.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  17. 17HumanNon-randomized trialMechanism

    In healthy men, pasireotide 200 and 600 μg inhibited growth hormone.

    In plain wordsIn healthy men, pasireotide 200 and 600 μg suppressed growth hormone.

    Outcome
    DecreaseGrowth hormone inhibition
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    200 and 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Growth hormone inhibition was observed with pasireotide 200 and 600 μg sc qd.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  18. 18HumanNon-randomized trialMechanism

    In healthy men, postprandial gallbladder volume increased with pasireotide 200 and 600 μg.

    In plain wordsIn healthy men, gallbladder volume after meals increased with pasireotide 200 and 600 μg.

    Outcome
    IncreasePostprandial gallbladder volume
    Study

    n: not reported in source

    Outcome group
    Receptor activity and mechanism · Gastrointestinal
    Studied dose
    200 and 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Gallbladder volume increased post-prandially with pasireotide 200 and 600 μg sc qd, which appeared to correlate with reduced levels of cholecystokinin at these doses.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  19. 19HumanNon-randomized trialMechanism

    In healthy men, cholecystokinin levels decreased with pasireotide 200 and 600 μg.

    In plain wordsIn healthy men, cholecystokinin levels decreased with pasireotide 200 and 600 μg.

    Outcome
    DecreaseCholecystokinin levels
    Study

    n: not reported in source

    Outcome group
    Receptor activity and mechanism · Gastrointestinal
    Studied dose
    200 and 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Gallbladder volume increased post-prandially with pasireotide 200 and 600 μg sc qd, which appeared to correlate with reduced levels of cholecystokinin at these doses.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.
  20. 20HumanObservational studyOther

    In healthy men receiving pasireotide, increased postprandial gallbladder volume appeared to correlate with reduced cholecystokinin at 200 and 600 μg.

    In plain wordsIn healthy men receiving pasireotide, larger gallbladder volume after meals appeared linked to lower cholecystokinin.

    Outcome
    MixedGallbladder volume and cholecystokinin association
    Study

    n: not reported in source

    Outcome group
    Receptor activity and mechanism · Gastrointestinal
    Studied dose
    200 and 600 μg once daily · subcutaneous · 14 daysAs given in this study (human).

    Source sentences

    Summary
    Gallbladder volume increased post-prandially with pasireotide 200 and 600 μg sc qd, which appeared to correlate with reduced levels of cholecystokinin at these doses.
    2 context sentences
    Summary · context
    A randomized, double-blind, placebo-controlled, cross-over, dose-escalating, single-center study was conducted to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of multiple once-daily (qd) subcutaneous (sc) doses of pasireotide in healthy male subjects.
    Summary · context
    Subjects received pasireotide 50, 200, or 600 μg sc qd for 14 days and placebo in separate sequences.

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:34 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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