Safety Study of Omecamtiv Mecarbil in Healthy Japanese Subjects
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|ClinicalTrials.gov Identifier: NCT02601001|
Recruitment Status : Completed
First Posted : November 10, 2015
Last Update Posted : January 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: AMG 423 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 1, Single Center Double-blind, Randomized, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of Omecamtiv Mecarbil in Healthy Japanese Subjects|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Placebo Comparator: Treatment group C
Active Comparator: Treatment group A
25 mg and 37.5 mg
Drug: AMG 423
Omecamtiv mecarbil at 25 mg and 37.5 mg
Active Comparator: Treatment group B
25 mg and 50 mg
Drug: AMG 423
Omecamtiv mercabil at 25 mg and 50 mg
- Pharmacokinetics (Cmax) [ Time Frame: Day 1, Day 8, Day 20, Day 27 ]Cmax of omecamtiv mecarbil following dose administration on Days 1, 8, 20, and 27.
- Incidence of Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 35 days ]1. Subject incidence of adverse events 2. Changes from baseline in laboratory values and vital signs 3. Changes from baseline in electrocardiogram (ECG)
- Pharmacokinetics (AUC) [ Time Frame: Day 1, Day 8, Day 20, Day 27 ]AUC12h of omecamtiv mecarbil following dose administration on Days 1, 8, 20, and 27.
- Pharmacokinetics (Tmax) [ Time Frame: Day 1, Day 8, Day 20, Day 27 ]Tmax of omecamtiv mecarbil following dose administration on Days 1, 8, 20, and 27.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601001
|Kagoshima-shi, Kagoshima, Japan, 890-0081|