Safety, Tolerability and Pharmacokinetics Study of CK-3773274

Phase 1

Completed

• Conditions: Obstructive Hypertrophic Cardiomyopathy; Healthy Adult Subjects
• Interventions: Drug: CK-3773274; Drug: Placebo

• Registration Number: NCT04783766
• Lead Sponsor: Corxel Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-05
• Study Start: 2021-04-10
• Primary Completion: 2021-08-05
• Study Completion: 2021-08-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CK-3773274 for Single Ascending Dose (SAD) Cohorts	CK-3773274	Subjects will be assigned to one of 2 planned dose cohorts and receive single doses of CK-3773274
CK-3773274 for Multiple Dose (MD) Cohort	CK-3773274	Subjects will receive multiple doses of CK-3773274
Placebo comparator for MD Cohort	Placebo	Subjects will receive multiple doses of placebo comparator
Placebo comparator for SAD Cohorts	Placebo	Subjects will be assigned to one of 2 planned dose cohorts and receive single doses of placebo comparator

Primary Outcome Measures

Name	Time	Method
Subject incidence of Adverse Event (AE), Serious Adverse Event (SAE)	SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23
Reduced Left Ventricular Ejection Fraction (LVEF)	SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23

Secondary Outcome Measures

Name	Time	Method
Cmax of CK-3773274 after single and multiple ascending doses	SAD Cohorts: Day-1 - Day10; MD Cohort: Day-1 - Day 23

Trial Locations

Locations (1)

Clinical Site; 🇨🇳 Beijing, Beijing, China