* To evaluate pharmacokinetics (PK) of omecamtiv mecarbil in Japanese subjects with heart failure (HF) with reduced ejection fraction * To evaluate the safety and tolerability of oral omecamtiv mecarbil
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
Research Site
Kasugai-shi, Aichi-ken, Japan
Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time
Time frame: Before morning dose on Week 2 (Day 15), Week 4 (Day 28), Week 12 (Day 84), Week 16 (Day 112)
PK: Area Under the Curve Until 8 Hours After Morning Dose at Week 8 (AUC0-8)
Time frame: Week 8 (Day 56) at predose, at 2 hours ±30 minutes; 4 hours ±30 minutes; 6 hours ±30 minutes; 8 hours ±30 minutes after morning dose
Change From Baseline at Week 16 in Systolic Ejection Time (SET)
LS mean was from the repeated measures model, which included treatment group, stratification factor (from IVRS), scheduled visit, baseline value, and the interaction of treatment group with scheduled visit as covariates.
Time frame: Baseline, Week 16 (Day 112)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
oral tablet
Research Site
Kasugai-shi, Aichi-ken, Japan
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Asahi-shi, Chiba, Japan
Research Site
Chiba, Chiba, Japan
Research Site
Imabari, Ehime, Japan
Research Site
Chikushino-shi, Fukuoka, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Hakodate-shi, Hokkaido, Japan
...and 22 more locations