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Study · Randomized controlled trial · 2014

5 results

Effects of Subcutaneous Pasireotide on Cardiac Repolarization in Healthy Volunteers: a Single‐Center, Phase I, Randomized, Four‐Way Crossover Study.

Breitschaft A, Hu K, Darstein C, Ligueros-Saylan M, Jordaan P, Song D, Hudson M, Shah R

Journal of clinical pharmacology1 Jan 2014Cited by 18 (Europe PMC)

PMID24242903 (opens in a new tab)PMCIDPMC4272414 (opens in a new tab)DOI10.1002/jcph.213 (opens in a new tab)PepBankPUB-24242903
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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In healthy volunteers, pasireotide 600 µg bid produced maximum mean ΔΔQTcI of 13.2 milliseconds (90% CI 11.4, 15.0) at 2 hours post-dose.

    In plain wordsIn healthy volunteers, pasireotide 600 µg bid prolonged corrected QT by 13.2 milliseconds relative to placebo.

    Peptide
    Pasireotide
    Outcome
    IncreaseQTcI prolongation, therapeutic dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    600 µg bid · subcutaneousAs given in this study (human).

    Measurements

    Mean placebo-subtracted ΔQTcI (ΔΔQTcI)
    13.2 milliseconds
    pasireotide 600 µg bid, maximum at 2 hours post-dose
    90% CI of mean ΔΔQTcI
    11.4 to 15 milliseconds
    pasireotide 600 µg bid

    Source sentences

    Summary
    Mean ΔΔQTcI was 13.2 milliseconds (90% CI: 11.4, 15.0) and 16.1 milliseconds (90% CI: 14.3, 17.9) for the 600 and 1,950 µg bid doses, respectively.
    3 context sentences
    Summary · context
    Maximum ΔΔQTcI occurred 2 hours post-dose for both doses of pasireotide.
    Summary · context
    The aim of this study was to evaluate the effects of subcutaneous pasireotide on cardiac repolarization in healthy volunteers.
    Summary · context
    Healthy volunteers were randomized to one of four treatment sequences (n = 112) involving four successive treatments in different order: pasireotide 600 µg (therapeutic dose) or 1,950 µg (maximum tolerated dose) bid by subcutaneous injection (sc), placebo injection and oral moxifloxacin.
  2. 02HumanRandomized controlled trialSafety outcome

    In healthy volunteers, pasireotide 1,950 µg bid produced maximum mean ΔΔQTcI of 16.1 milliseconds (90% CI 14.3, 17.9) at 2 hours post-dose.

    In plain wordsIn healthy volunteers, pasireotide 1,950 µg bid prolonged corrected QT by 16.1 milliseconds relative to placebo.

    Peptide
    Pasireotide
    Outcome
    IncreaseQTcI prolongation, maximum tolerated dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    1,950 µg bid · subcutaneousAs given in this study (human).

    Measurements

    Mean placebo-subtracted ΔQTcI (ΔΔQTcI)
    16.1 milliseconds
    pasireotide 1,950 µg bid, maximum at 2 hours post-dose
    90% CI of mean ΔΔQTcI
    14.3 to 17.9 milliseconds
    pasireotide 1,950 µg bid

    Source sentences

    Summary
    Mean ΔΔQTcI was 13.2 milliseconds (90% CI: 11.4, 15.0) and 16.1 milliseconds (90% CI: 14.3, 17.9) for the 600 and 1,950 µg bid doses, respectively.
    3 context sentences
    Summary · context
    Maximum ΔΔQTcI occurred 2 hours post-dose for both doses of pasireotide.
    Summary · context
    The aim of this study was to evaluate the effects of subcutaneous pasireotide on cardiac repolarization in healthy volunteers.
    Summary · context
    Healthy volunteers were randomized to one of four treatment sequences (n = 112) involving four successive treatments in different order: pasireotide 600 µg (therapeutic dose) or 1,950 µg (maximum tolerated dose) bid by subcutaneous injection (sc), placebo injection and oral moxifloxacin.
  3. 03HumanRandomized controlled trialSafety outcome

    In healthy volunteers, pasireotide 600 µg bid reduced heart rate by 10.4 bpm versus placebo, maximally at 1 hour.

    In plain wordsIn healthy volunteers, pasireotide 600 µg bid reduced heart rate by 10.4 bpm compared with placebo.

    Peptide
    Pasireotide
    Outcome
    DecreaseHeart rate, therapeutic dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    600 µg bid · subcutaneousAs given in this study (human).

    Measurements

    Maximal heart rate reduction versus placebo
    10.4 bpm
    pasireotide 600 µg bid
    Time of maximal heart rate change
    1 hours
    pasireotide 600 µg bid

    Source sentences

    Summary
    Both pasireotide doses caused a reduction in heart rate: maximal heart rate change compared with placebo occurred at 1 hour for pasireotide 600 µg bid and at 0.5 hours for pasireotide 1,950 µg bid, with heart rate reductions of 10.4 and 14.9 bpm, respectively.
    2 context sentences
    Summary · context
    The aim of this study was to evaluate the effects of subcutaneous pasireotide on cardiac repolarization in healthy volunteers.
    Summary · context
    Healthy volunteers were randomized to one of four treatment sequences (n = 112) involving four successive treatments in different order: pasireotide 600 µg (therapeutic dose) or 1,950 µg (maximum tolerated dose) bid by subcutaneous injection (sc), placebo injection and oral moxifloxacin.
  4. 04HumanRandomized controlled trialSafety outcome

    In healthy volunteers, pasireotide 1,950 µg bid reduced heart rate by 14.9 bpm versus placebo, maximally at 0.5 hours.

    In plain wordsIn healthy volunteers, pasireotide 1,950 µg bid reduced heart rate by 14.9 bpm compared with placebo.

    Peptide
    Pasireotide
    Outcome
    DecreaseHeart rate, maximum tolerated dose
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Heart function · Cardiovascular
    Studied dose
    1,950 µg bid · subcutaneousAs given in this study (human).

    Measurements

    Maximal heart rate reduction versus placebo
    14.9 bpm
    pasireotide 1,950 µg bid
    Time of maximal heart rate change
    0.5 hours
    pasireotide 1,950 µg bid

    Source sentences

    Summary
    Both pasireotide doses caused a reduction in heart rate: maximal heart rate change compared with placebo occurred at 1 hour for pasireotide 600 µg bid and at 0.5 hours for pasireotide 1,950 µg bid, with heart rate reductions of 10.4 and 14.9 bpm, respectively.
    2 context sentences
    Summary · context
    The aim of this study was to evaluate the effects of subcutaneous pasireotide on cardiac repolarization in healthy volunteers.
    Summary · context
    Healthy volunteers were randomized to one of four treatment sequences (n = 112) involving four successive treatments in different order: pasireotide 600 µg (therapeutic dose) or 1,950 µg (maximum tolerated dose) bid by subcutaneous injection (sc), placebo injection and oral moxifloxacin.
  5. 05HumanNon-randomized trialSafety outcome

    In healthy volunteers, no safety concerns for pasireotide were identified during the study.

    In plain wordsIn healthy volunteers, the study identified no safety concerns for pasireotide.

    Peptide
    Pasireotide
    Outcome
    Not applicableOverall safety concerns
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    600 or 1,950 µg bid · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    No safety concerns for pasireotide were identified during the study.
    2 context sentences
    Summary · context
    The aim of this study was to evaluate the effects of subcutaneous pasireotide on cardiac repolarization in healthy volunteers.
    Summary · context
    Healthy volunteers were randomized to one of four treatment sequences (n = 112) involving four successive treatments in different order: pasireotide 600 µg (therapeutic dose) or 1,950 µg (maximum tolerated dose) bid by subcutaneous injection (sc), placebo injection and oral moxifloxacin.

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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