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

Amgen

Status and phase: Completed; Phase 1

Conditions: Basic Science

Treatments: Drug: Moxifloxacin; Drug: Olpasiran; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06411860

20220016

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provide informed consent prior to starting study activities.
• Healthy male or female participants, between 18 and 60 years of age (inclusive) at the time of Screening. Females must be of nonchildbearing potential.
• Body mass index between 18 and 30 kg/m^2 (inclusive) at the time of Screening. Participants must have a body mass ≥ 50kg.

Exclusion criteria

• History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
• History or current signs or symptoms of cardiovascular disease, including but not limited to myocardial infarction, congenital heart disease, valvular heart disease coronary revascularization, or angina.
• History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at Check-in.
• Systolic blood pressure > 150 mmHg or < 90 mmHg, or diastolic blood pressure > 90 mmHg or < 50 mmHg, or HR ≤ 40 and > 100 bpm, at Screening or Check-in; one repeat blood pressure measurement will be allowed at Screening and Check-in.
• History suggestive of esophageal (including esophageal spasm, esophagitis), gastric, or duodenal ulceration or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome), or a history of gastrointestinal surgery other than uncomplicated appendectomy and hernia repair.
• Inability to swallow oral medication or history of malabsorption syndrome.
• History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
• History of major bleeding disorder (for example: hemophilia, von Willebrand disease, clotting factor deficiencies, etc).
• Participant has received a dose of an investigational drug within the past 90 days or have previously completed or withdrawn from this study or any other study investigating olpasiran or have previously received olpasiran.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 4 patient groups, including a placebo group

Treatment A

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Treatment B

Experimental group

Description:

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

Treatment:

Drug: Olpasiran

Treatment C

Experimental group

Description:

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

Treatment:

Drug: Olpasiran

Treatment D

Active Comparator group

Description:

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

Treatment:

Drug: Moxifloxacin