Trials / Completed
CompletedNCT02601001
Pharmacokinetics and Safety Study of Omecamtiv Mecarbil in Healthy Japanese Adults
A Phase 1, Single Center Double-blind, Randomized, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of Omecamtiv Mecarbil in Healthy Japanese Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Cytokinetics · Industry
- Sex
- All
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of omecamtiv mecarbil in healthy volunteers in Japan.
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Omecamtiv mecarbil | Omecamtiv mecarbil tablets for oral administration |
| DRUG | Placebo | Matching placebo tablets |
Timeline
- Start date
- 2015-11-13
- Primary completion
- 2016-01-06
- Completion
- 2016-01-06
- First posted
- 2015-11-10
- Last updated
- 2021-07-27
- Results posted
- 2021-05-18
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02601001. Inclusion in this directory is not an endorsement.