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

Basic Science Clinical Trial

Official title:

A Randomized, Placebo- and Positive-controlled, Crossover Study to Assess the Effect of Olpasiran (AMG 890) on QT/QTc Intervals in Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06411860
• Other study ID #: 20220016
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 8, 2024
• Est. completion date: October 28, 2024

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: October 28, 2024
• Est. primary completion date: October 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Basic Science

Intervention

Other:
• Placebo
Participants will receive a subcutaneous (SC) injection of placebo.

Drug:
• Olpasiran
Participants will receive a SC injection of olpasiran at dose level 1 or 2.
• Moxifloxacin
Participants will receive a single dose of moxifloxacin as an oral tablet by mouth.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placebo-corrected Change From Baseline in QT Corrected for Heart Rate (HR) Interval Based on the Fridericia Correction (QTcF) (??QTcF) After Olpasiran Dosing		Day 3 of Treatment Period 4 (up to approximately 9.5 weeks)
Secondary	Maximum Observed Concentration (Cmax) of Olpasiran		Up to 10 weeks
Secondary	Time to Cmax (tmax) of Olpasiran		Up to 10 weeks
Secondary	Half-life of Olpasiran (t1/2)		Up to 10 weeks
Secondary	Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast)		Up to 10 weeks
Secondary	Area Under the Curve From Time 0 to Infinity (AUCinf)		Up to 10 weeks
Secondary	Change From Baseline in HR		Up to 10 weeks
Secondary	Change From Baseline in QTcF		Up to 10 weeks
Secondary	Change From Baseline in PR Interval		Up to 10 weeks
Secondary	Change From Baseline in QRS Interval		Up to 10 weeks
Secondary	Placebo-corrected Change From Baseline in HR		Up to 10 weeks
Secondary	Placebo-corrected Change From Baseline in PR Interval		Up to 10 weeks
Secondary	Placebo-corrected Change From Baseline in QRS Interval		Up to 10 weeks
Secondary	Number of Participants with Categorical Outliers Related to the Following ECG parameter: QTcF, HR, PR, and QRS		Up to 10 weeks
Secondary	Frequency of Treatment-emergent Changes in Electrocardiogram (ECG) Morphology		Up to 10 weeks
Secondary	??QTcF After Moxifloxacin Dosing		Up to 10 weeks
Secondary	Number of Participants With Treatment-emergent Adverse Events		Up to 10 weeks
Secondary	Number of Participants With Treatment-emergent Serious Adverse Events		Up to 10 weeks

External Links

•   AmgenTrials clinical trials website