NCT03767855

A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multi-Part, Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Cytokinetics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purposes of this study are to: 1. Learn about the safety of CK-3773274 after a single dose and multiple doses in healthy subjects. 2. Learn how healthy subjects tolerate CK-3773274 after a single dose and multiple doses. 3. Find out how much CK-3773274 is in the blood after a single dose and multiple doses. 4. Determine the effect of doses of CK-3773274 on the pumping function of the heart. 5. Evaluate the effect of cytochrome genetic variants on how the body metabolizes CK-3773274. 6. Evaluate the effect of a meal on how much CK-3773274 is in the blood in healthy adult subjects. 7. Evaluate whether the amount of CK-3773274 in the blood is the similar for both the tablet and granules in capsule forms of the drug.

Conditions

• Symptomatic Obstructive Hypertrophic Cardiomyopathy
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	CK-3773274 - Granules in Capsule	CK-3773274 formulated as granules in capsule
DRUG	Placebo - Granules in Capsule	Placebo formulated as granules in capsule
DRUG	CK-3773274 - Tablets	CK-3773274 formulated as tablets

Timeline

• Start date: 2018-12-04
• Primary completion: 2020-01-03
• Completion: 2020-01-03
• First posted: 2018-12-07
• Last updated: 2025-01-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study