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Completed

NCT Number: NCT04783766

Safety, Tolerability and Pharmacokinetics Study of CK-3773274

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Site

Beijing, Beijing Municipality, 100032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CK-3773274

Drug

CK-3773274- Tablets

Placebo

Drug

Placebo- Tablets

Primary outcomes

  1. Subject incidence of Adverse Event (AE), Serious Adverse Event (SAE)

    Time frame: SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23

  2. Reduced Left Ventricular Ejection Fraction (LVEF)

    Time frame: SAD cohorts: Day-1 - Day10; MD cohort: Day-1 - Day 23

Secondary outcomes

  1. Cmax of CK-3773274 after single and multiple ascending doses

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

Sponsors and collaborators

Lead sponsor

Corxel Pharmaceuticals

Industry

Collaborators

  • Cytokinetics

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2021
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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