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

NCT03767855 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-01-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Cytokinetics

    lead INDUSTRY

Principal Investigators

  • Study Director MD · Cytokinetics

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-04
Primary Completion
2020-01-03
Completion
2020-01-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03767855 on ClinicalTrials.gov