Safety, Tolerability and Pharmacokinetics Study of CK-3773274

NCT ID: NCT04783766

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-10
• Study Completion Date: 2021-08-05

Brief Summary

The purposes of this study are to:

1. Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult 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 CYP2D6 genetic polymorphisms on how the body metabolizes CK-3773274.

Conditions

Obstructive Hypertrophic Cardiomyopathy; Healthy Adult Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

CK-3773274 for Single Ascending Dose (SAD) Cohorts

Subjects will be assigned to one of 2 planned dose cohorts and receive single doses of CK-3773274

Group Type: EXPERIMENTAL

CK-3773274

Intervention Type: DRUG

CK-3773274- Tablets

Placebo comparator for SAD Cohorts

Subjects will be assigned to one of 2 planned dose cohorts and receive single doses of placebo comparator

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo- Tablets

CK-3773274 for Multiple Dose (MD) Cohort

Subjects will receive multiple doses of CK-3773274

Group Type: EXPERIMENTAL

CK-3773274

Intervention Type: DRUG

CK-3773274- Tablets

Placebo comparator for MD Cohort

Subjects will receive multiple doses of placebo comparator

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo- Tablets

Interventions

CK-3773274

CK-3773274- Tablets

Intervention Type: DRUG

Placebo

Placebo- Tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy Chinese males and females between 18 and 45 years of age, inclusive

2. Body weight ≥50kg and body mass index (BMI) within 18 to 26 kg/m2, inclusive

3. Acoustic windows adequate for accurate transthoracic echocardiograms

4. Normal cardiac structure and function, as determined by the cardiologist, or if abnormalities are present, the finding is not clinically significant as determined by the cardiologist

5. LVEF ≥65 percent at screening, and LVEF ≥60 percent at Day-1

6. Normal ECG

Exclusion Criteria

1. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs

2. Subjects with breast implants that may impede echocardiography

3. A clinically significant illness within 4 weeks prior to admission to the CRU

4. Inability to swallow tablets

5. Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages within 48 hours prior to admission to the CRU

6. Poor peripheral venous access

7. Any blood donation within 60 days prior to admission to the CRU, or any plasma donation within 30 days prior to admission to the CRU, or receipt of blood products within 2 months prior to admission to the CRU

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cytokinetics

INDUSTRY

Sponsor Role: collaborator

Corxel Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chen, MD

Role: STUDY_DIRECTOR

Corxel Pharmaceuticals

Locations

Clinical Site

Beijing, Beijing Municipality, China

Countries

China

References

Zhao X, Liu H, Tian W, Fang L, Yu M, Wu X, Liu A, Wan R, Li L, Luo J, Li Y, Liu B, He Y, Chen X, Li Y, Xu D, Wang H, Han X. Safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of aficamten in healthy Chinese participants: a randomized, double-blind, placebo-controlled, phase 1 study. Front Pharmacol. 2023 Aug 23;14:1227470. doi: 10.3389/fphar.2023.1227470. eCollection 2023.

Reference Type: DERIVED

PMID: 37680714 (View on PubMed)

Other Identifiers

CTR20210291

Identifier Type: OTHER

Identifier Source: secondary_id

JX01001

Identifier Type: -

Identifier Source: org_study_id