Safety, Tolerability and Pharmacokinetics Study of CK-3773274

Corxel Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Obstructive Hypertrophic Cardiomyopathy; Healthy Adult Subjects

Treatments: Drug: CK-3773274; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04783766

CTR20210291 (Other Identifier)

JX01001

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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28 participants in 4 patient groups, including a placebo group

CK-3773274 for Single Ascending Dose (SAD) Cohorts

Experimental group

Description:

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

Treatment:

Drug: CK-3773274

Placebo comparator for SAD Cohorts

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

CK-3773274 for Multiple Dose (MD) Cohort

Experimental group

Description:

Subjects will receive multiple doses of CK-3773274

Treatment:

Drug: CK-3773274

Placebo comparator for MD Cohort

Placebo Comparator group

Description:

Subjects will receive multiple doses of placebo comparator

Treatment:

Drug: Placebo