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Study · Randomized controlled trial · 2024

9 results

Pharmacokinetics and pharmacodynamics of a pasireotide subcutaneous depot (CAM4071) and comparison with immediate and long-acting release pasireotide.

Johnsson M, Pedroncelli AM, Hansson A, Tiberg F

Endocrine29 Feb 2024Cited by 6 (Europe PMC)

PMID38421556 (opens in a new tab)DOI10.1007/s12020-024-03741-3 (opens in a new tab)PepBankPUB-38421556
Publisher pagePubMedAsk about this study
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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 study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, pasireotide CAM4071 showed faster initial release than pasireotide LAR at all CAM4071 doses.

    In plain wordsIn healthy volunteers, pasireotide CAM4071 released faster initially than pasireotide LAR.

    Peptide
    Pasireotide
    Outcome
    IncreaseInitial release
    Study

    n: not reported in source

    Comparator
    Pasireotide LAR
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5, 10, 20, 40 or 80 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    For all CAM4071 doses, initial pasireotide release was relatively rapid compared to pasireotide LAR and sustained over the 2-month observation period, with a slow decay in plasma concentrations.
    1 context sentence
    Summary · context
    This was a phase 1, randomised, open-label study in healthy volunteers.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy volunteers, CAM4071 relative bioavailability versus pasireotide LAR ranged from 0.517 (90% CI 0.37, 0.72) to 1.15 (0.84, 1.58).

    In plain wordsIn healthy volunteers, CAM4071 relative bioavailability versus pasireotide LAR ranged from 0.517 to 1.15.

    Peptide
    Pasireotide
    Outcome
    MixedRelative bioavailability versus LAR
    Study

    n: not reported in source

    Comparator
    Pasireotide LAR
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5, 10, 20, 40 or 80 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    Relative bioavailability versus pasireotide LAR, lowest dose ratio
    0.517 ratio
    CAM4071 versus pasireotide LAR, 90% CI 0.37 to 0.72
    Relative bioavailability versus pasireotide LAR, highest dose ratio
    1.15 ratio
    CAM4071 versus pasireotide LAR, 90% CI 0.84 to 1.58
    90% CI of lowest ratio versus LAR
    0.37 to 0.72 ratio
    CAM4071 versus pasireotide LAR, ratio 0.517
    90% CI of highest ratio versus LAR
    0.84 to 1.58 ratio
    CAM4071 versus pasireotide LAR, ratio 1.15

    Source sentences

    Summary
    Relative bioavailability of pasireotide for different doses of CAM4071 versus pasireotide IR 600 μg ranged from 0.752 (90% confidence interval [CI]: 0.58, 0.98) to 1.68 (1.32, 2.14), and versus pasireotide LAR: 0.517 (0.37, 0.72) to 1.15 (0.84, 1.58).
    1 context sentence
    Summary · context
    This was a phase 1, randomised, open-label study in healthy volunteers.
  3. 03HumanRandomized controlled trialActivity measurement

    In healthy volunteers, pasireotide CAM4071 doses >5 mg produced rapid initial IGF-1 reductions compared with pasireotide LAR.

    In plain wordsIn healthy volunteers, pasireotide CAM4071 doses >5 mg reduced IGF-1 rapidly compared with pasireotide LAR.

    Peptide
    Pasireotide
    Outcome
    DecreaseInitial IGF-1 reduction
    Study

    n: not reported in source

    Comparator
    Pasireotide LAR
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    >5 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    CAM4071 doses >5 mg exhibited rapid initial reductions of insulin-like growth factor 1 (IGF-1) compared to pasireotide LAR.
    1 context sentence
    Summary · context
    This was a phase 1, randomised, open-label study in healthy volunteers.
  4. 04HumanRandomized controlled trialActivity measurement

    In healthy volunteers, maximum IGF-1 inhibition was greatest with pasireotide CAM4071 80 mg.

    In plain wordsIn healthy volunteers, pasireotide CAM4071 80 mg suppressed IGF-1 most strongly among the CAM4071 doses.

    Peptide
    Pasireotide
    Outcome
    IncreaseMaximum IGF-1 inhibition
    Study

    n: not reported in source

    Comparator
    Other CAM4071 doses
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    80 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    Maximum IGF-1 inhibition was greatest for CAM4071 80 mg.
    1 context sentence
    Summary · context
    This was a phase 1, randomised, open-label study in healthy volunteers.
  5. 05HumanRandomized controlled trialSafety outcome

    In healthy volunteers, pasireotide CAM4071 injections ≤40 mg were well tolerated, comparably to currently available pasireotide formulations.

    In plain wordsIn healthy volunteers, pasireotide CAM4071 injections ≤40 mg had tolerability comparable with currently available pasireotide formulations.

    Peptide
    Pasireotide
    Outcome
    Direction not reportedTolerability
    Study

    n: not reported in source

    Comparator
    Currently available pasireotide formulations
    Outcome group
    Adverse events · Whole body
    Studied dose
    ≤40 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    CAM4071 injections ≤40 mg were well tolerated and comparable with currently available pasireotide formulations.
    1 context sentence
    Summary · context
    This was a phase 1, randomised, open-label study in healthy volunteers.
  6. 06HumanNon-randomized trialPharmacokinetics

    In healthy volunteers, pasireotide CAM4071 release persisted over the 2-month observation period with slowly declining plasma concentrations.

    In plain wordsIn healthy volunteers, pasireotide CAM4071 release persisted over the 2-month observation period.

    Peptide
    Pasireotide
    Outcome
    Not applicableSustained release
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5, 10, 20, 40 or 80 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    For all CAM4071 doses, initial pasireotide release was relatively rapid compared to pasireotide LAR and sustained over the 2-month observation period, with a slow decay in plasma concentrations.
    1 context sentence
    Summary · context
    This was a phase 1, randomised, open-label study in healthy volunteers.
  7. 07HumanNon-randomized trialPharmacokinetics

    In healthy volunteers, pasireotide CAM4071 maximum plasma concentrations increased slightly more than dose proportionally.

    In plain wordsIn healthy volunteers, pasireotide CAM4071 peak concentrations increased slightly more than proportionally with dose.

    Peptide
    Pasireotide
    Outcome
    IncreaseMaximum plasma concentration dose proportionality
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5, 10, 20, 40 or 80 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    CAM4071 maximum plasma concentrations increased slightly greater than dose proportionally; area under the curve extrapolated to infinity increased approximately dose proportionally.
    1 context sentence
    Summary · context
    This was a phase 1, randomised, open-label study in healthy volunteers.
  8. 08HumanNon-randomized trialPharmacokinetics

    In healthy volunteers, pasireotide CAM4071 area under the curve extrapolated to infinity increased approximately dose proportionally.

    In plain wordsIn healthy volunteers, pasireotide CAM4071 total exposure increased approximately proportionally with dose.

    Peptide
    Pasireotide
    Outcome
    IncreaseArea under the curve dose proportionality
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5, 10, 20, 40 or 80 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    CAM4071 maximum plasma concentrations increased slightly greater than dose proportionally; area under the curve extrapolated to infinity increased approximately dose proportionally.
    1 context sentence
    Summary · context
    This was a phase 1, randomised, open-label study in healthy volunteers.
  9. 09HumanNon-randomized trialPharmacokinetics

    In healthy volunteers, CAM4071 relative bioavailability versus pasireotide IR ranged from 0.752 (90% CI 0.58, 0.98) to 1.68 (1.32, 2.14).

    In plain wordsIn healthy volunteers, CAM4071 relative bioavailability versus pasireotide IR ranged from 0.752 to 1.68.

    Peptide
    Pasireotide
    Outcome
    MixedRelative bioavailability versus IR
    Study

    n: not reported in source

    Comparator
    Pasireotide IR 600 μg
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5, 10, 20, 40 or 80 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    Relative bioavailability versus pasireotide IR 600 ug, lowest dose ratio
    0.752 ratio
    CAM4071 versus pasireotide IR 600 ug, 90% CI 0.58 to 0.98
    Relative bioavailability versus pasireotide IR 600 ug, highest dose ratio
    1.68 ratio
    CAM4071 versus pasireotide IR 600 ug, 90% CI 1.32 to 2.14
    90% CI of lowest ratio versus IR
    0.58 to 0.98 ratio
    CAM4071 versus pasireotide IR 600 ug, ratio 0.752
    90% CI of highest ratio versus IR
    1.32 to 2.14 ratio
    CAM4071 versus pasireotide IR 600 ug, ratio 1.68

    Source sentences

    Summary
    Relative bioavailability of pasireotide for different doses of CAM4071 versus pasireotide IR 600 μg ranged from 0.752 (90% confidence interval [CI]: 0.58, 0.98) to 1.68 (1.32, 2.14), and versus pasireotide LAR: 0.517 (0.37, 0.72) to 1.15 (0.84, 1.58).
    1 context sentence
    Summary · context
    This was a phase 1, randomised, open-label study in healthy volunteers.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

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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