Safety, Tolerability and Pharmacokinetics Study of CK-3773274

Healthy Adult Subjects Clinical Trial

Official title:

A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CK-3773274 in Healthy Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783766
• Other study ID #: JX01001
• Secondary ID: CTR20210291
• Status: Completed
• Phase: Phase 1
• Start date: April 10, 2021
• Est. completion date: August 5, 2021

Study information

• Verified date: September 2021
• Source: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 5, 2021
• Est. primary completion date: August 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Healthy Adult Subjects
• Hypertrophy
• Obstructive Hypertrophic Cardiomyopathy

Intervention

Drug:
• CK-3773274
CK-3773274- Tablets
• Placebo
Placebo- Tablets

Locations

Country	Name	City	State
China	Clinical Site	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.	Cytokinetics

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject incidence of Adverse Event (AE), Serious Adverse Event (SAE)		SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23
Primary	Reduced Left Ventricular Ejection Fraction (LVEF)		SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23
Secondary	Cmax of CK-3773274 after single and multiple ascending doses		SAD Cohorts: Day-1 - Day10; MD Cohort: Day-1 - Day 23