NCT04783766

Brief Summary

The purposes of this study are to:

  1. 1.Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult subjects.
  2. 2.Learn how healthy subjects tolerate CK-3773274 after a single dose and multiple doses.
  3. 3.Find out how much CK-3773274 is in the blood after a single dose and multiple doses.
  4. 4.Determine the effect of doses of CK-3773274 on the pumping function of the heart.
  5. 5.Evaluate the effect CYP2D6 genetic polymorphisms on how the body metabolizes CK-3773274.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2021

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

March 3, 2021

Last Update Submit

January 22, 2025

Conditions

Obstructive Hypertrophic CardiomyopathyHealthy Adult Subjects

Keywords

CK-274Obstructive hypertrophic cardiomyopathyCK-3773274oHCMaficamten

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Cmax of CK-3773274 after single and multiple ascending doses

    SAD Cohorts: Day-1 - Day10; MD Cohort: Day-1 - Day 23

Study Arms (4)

CK-3773274 for Single Ascending Dose (SAD) Cohorts

EXPERIMENTAL

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

Drug: CK-3773274

Placebo comparator for SAD Cohorts

PLACEBO COMPARATOR

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

Drug: Placebo

CK-3773274 for Multiple Dose (MD) Cohort

EXPERIMENTAL

Subjects will receive multiple doses of CK-3773274

Drug: CK-3773274

Placebo comparator for MD Cohort

PLACEBO COMPARATOR

Subjects will receive multiple doses of placebo comparator

Drug: Placebo

Interventions

CK-3773274DRUG

CK-3773274- Tablets

CK-3773274 for Multiple Dose (MD) CohortCK-3773274 for Single Ascending Dose (SAD) Cohorts
PlaceboDRUG

Placebo- Tablets

Placebo comparator for MD CohortPlacebo comparator for SAD Cohorts

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Chinese males and females between 18 and 45 years of age, inclusive
  • Body weight ≥50kg and body mass index (BMI) within 18 to 26 kg/m2, inclusive
  • Acoustic windows adequate for accurate transthoracic echocardiograms
  • 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
  • LVEF ≥65 percent at screening, and LVEF ≥60 percent at Day-1
  • Normal ECG

You may not qualify if:

  • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
  • Subjects with breast implants that may impede echocardiography
  • A clinically significant illness within 4 weeks prior to admission to the CRU
  • Inability to swallow tablets
  • Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages within 48 hours prior to admission to the CRU
  • Poor peripheral venous access
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Site

Beijing, Beijing Municipality, 100032, China

Location

Related Publications (1)

  • 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.

    PMID: 37680714DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Officials

  • Chen, MD

    Corxel Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 5, 2021

Study Start

April 10, 2021

Primary Completion

August 5, 2021

Study Completion

August 5, 2021

Last Updated

January 24, 2025

Record last verified: 2025-01

Locations

CN(1)