A Study to Assess the Effect of Olpasiran on QT/QTc Intervals in Healthy Participants

Sponsor
Amgen
Study ID
NCT06411860
Phase
PHASE1
Status
Completed

Conditions

  • Basic Science

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — OTHER
    Participants will receive a subcutaneous (SC) injection of placebo.
  • Olpasiran — DRUG
    Participants will receive a SC injection of olpasiran at dose level 1 or 2.
  • Moxifloxacin — DRUG
    Participants will receive a single dose of moxifloxacin as an oral tablet by mouth.

Study Details

The primary objective of the study is: • To assess the effects of a single therapeutic and supratherapeutic dose of olpasiran on the placebo-corrected change from baseline in QT corrected for heart rate (ΔΔQT)/QTc interval in healthy participants.

Key Dates

Start date
Sep 12, 2024
Status verified
Oct 2025
Primary completion
Nov 29, 2024
Completion
Dec 11, 2024

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Treatment A
    All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin
  • Experimental: Treatment B
    All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin
  • Experimental: Treatment C
    All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin
  • Active Comparator: Treatment D
    All participants will be randomized to 1 of 12 treatment sequences and receive a single dose of one of the following treatments, according to the randomization schedule: Treatment A: placebo Treatment B: dose level 1 olpasiran Treatment C: dose level 2 olpasiran Treatment D: moxifloxacin

Primary Outcome Measure

Placebo-corrected Change From Baseline in QT Corrected for Heart Rate (HR) Interval Based on the Fridericia Correction (QTcF) (ΔΔQTcF) After Olpasiran Dosing [ Time Frame: Day 3 of Treatment Period 4 (up to approximately 9.5 weeks) ]

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