Trials / Completed
CompletedNCT03447990
v4 Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491
Randomized, Double-blind, Placebo-controlled, Two-Part, Adaptive Design Study of Safety, Tolerability, Preliminary Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of MYK-491 in Patients With Stable Heart Failure With Reduced Ejection Fraction
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this Phase 1b/2a study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MYK-491 in patients with stable heart failure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MYK-491 | Single Ascending Dose and Multiple Ascending Dose of MYK-491 |
| DRUG | Placebo | Single Ascending Dose and Multiple Ascending Dose of placebo |
Timeline
- Start date
- 2018-02-06
- Primary completion
- 2019-10-24
- Completion
- 2019-10-24
- First posted
- 2018-02-27
- Last updated
- 2023-02-02
- Results posted
- 2023-02-02
Locations
17 sites across 7 countries: United States, France, Germany, Netherlands, Poland, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03447990. Inclusion in this directory is not an endorsement.