NCT04175808

Study to Assess the Effect of Omecamtiv Mecarbil (OM) on QT/QTc Intervals in Healthy Adults

Single-dose and Randomized, Single-center, Placebo- and Active-controlled, Crossover Study to Assess the Effect of Omecamtiv Mecarbil (OM) on QT/QTc Intervals in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to assess the effect of a single therapeutic (50 mg) oral dose of omecamtiv mecarbil (OM) on the QT interval / QT interval corrected for heart rate (QTc), relative to placebo, in healthy adults. The QT interval is the section on an electrocardiogram (ECG) that represents the time it takes for the electrical system to fire an impulse through the ventricles and then recharge, or the time it takes for the heart muscle to contract and then recover.

Detailed description

The study consists of 2 parts: Part A and Part B. Participants are enrolled in Part A to determine eligibility for Part B. In Part A participants receive a single oral dose of 25 mg omecamtiv mecarbil; participants with a resulting maximum observed OM plasma concentration (Cmax) ≤ 350 ng/mL are eligible to enter Part B. Part B is a 3-period cross-over study in which participants are randomized to receive 3 treatments in 1 of 6 sequences, each separated by a washout of at least 7 days. This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Conditions

• QT Intervals Changes
• QTc Intervals Changes

Interventions

Type	Name	Description
DRUG	Omecamtiv Mecarbil (OM)	Oral solution
DRUG	Placebo	Placebo oral solution
DRUG	Moxifloxacin	400 mg moxifloxacin oral tablet

Timeline

• Start date: 2019-11-14
• Primary completion: 2020-03-04
• Completion: 2020-03-04
• First posted: 2019-11-25
• Last updated: 2025-03-30
• Results posted: 2021-07-20

Locations

1 site across 1 country: United Kingdom