Safety, Tolerability and Pharmacokinetics Study of CK-3773274

September 12, 2021 updated by: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100032
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CK-3773274 for Single Ascending Dose (SAD) Cohorts
Subjects will be assigned to one of 2 planned dose cohorts and receive single doses of CK-3773274
CK-3773274- Tablets
Placebo Comparator: Placebo comparator for SAD Cohorts
Subjects will be assigned to one of 2 planned dose cohorts and receive single doses of placebo comparator
Placebo- Tablets
Experimental: CK-3773274 for Multiple Dose (MD) Cohort
Subjects will receive multiple doses of CK-3773274
CK-3773274- Tablets
Placebo Comparator: Placebo comparator for MD Cohort
Subjects will receive multiple doses of placebo comparator
Placebo- Tablets

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Chen, MD, Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2021

Primary Completion (Actual)

August 5, 2021

Study Completion (Actual)

August 5, 2021

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 17, 2021

Last Update Submitted That Met QC Criteria

September 12, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Adult Subjects

Clinical Trials on CK-3773274

3
Subscribe