Clinical trial NCT04783766: Safety, Tolerability and Pharmacokinetics Study of CK-3773274
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obstructive Hypertrophic Cardiomyopathy
Healthy Adult Subjects
Keywords: CK-274
Obstructive hypertrophic cardiomyopathy
CK-3773274
oHCM
aficamten
Lead sponsor: Corxel Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Cytokinetics
First posted: 2021-03-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Subject incidence of Adverse Event (AE), Serious Adverse Event (SAE)
timeFrame: SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23
measure: Reduced Left Ventricular Ejection Fraction (LVEF)
timeFrame: SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23
Secondary outcomes:
measure: Cmax of CK-3773274 after single and multiple ascending doses
timeFrame: SAD Cohorts: Day-1 - Day10; MD Cohort: Day-1 - Day 23
Other outcomes:
Locations:
city: Beijing
country: China
facility: Clinical Site
state: Beijing
Study officials:
affiliation: Corxel Pharmaceuticals
name: Chen, MD
role: STUDY_DIRECTOR
References: