- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04783766
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:
- Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult subjects.
- Learn how healthy subjects tolerate CK-3773274 after a single dose and multiple doses.
- Find out how much CK-3773274 is in the blood after a single dose and multiple doses.
- Determine the effect of doses of CK-3773274 on the pumping function of the heart.
- Evaluate the effect CYP2D6 genetic polymorphisms on how the body metabolizes CK-3773274.
Study Overview
Status
Completed
Intervention / Treatment
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:
- 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
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- JX01001
- CTR20210291 (Other Identifier: China CDE clinical trial registration)
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.
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