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Safety, Tolerability and Pharmacokinetics Study of CK-3773274

Primary Purpose

Obstructive Hypertrophic Cardiomyopathy, Healthy Adult Subjects

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CK-3773274

Placebo

About this trial

This is an interventional basic science trial for Obstructive Hypertrophic Cardiomyopathy focused on measuring CK-274, Obstructive hypertrophic cardiomyopathy, CK-3773274, oHCM

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

CK-3773274 for Single Ascending Dose (SAD) Cohorts

Placebo comparator for SAD Cohorts

CK-3773274 for Multiple Dose (MD) Cohort

Placebo comparator for MD Cohort

Arm Description

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

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

Subjects will receive multiple doses of CK-3773274

Subjects will receive multiple doses of placebo comparator

Outcomes

Primary Outcome Measures

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

Reduced Left Ventricular Ejection Fraction (LVEF)

Secondary Outcome Measures

Cmax of CK-3773274 after single and multiple ascending doses

Full Information

NCT ID

NCT04783766

First Posted

March 3, 2021

Last Updated

September 12, 2021

Sponsor

Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

Collaborators

Cytokinetics

1. Study Identification

Unique Protocol Identification Number

NCT04783766

Brief Title

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

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

April 10, 2021 (Actual)

Primary Completion Date

August 5, 2021 (Actual)

Study Completion Date

August 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

Collaborators

Cytokinetics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Hypertrophic Cardiomyopathy, Healthy Adult Subjects

Keywords

CK-274, Obstructive hypertrophic cardiomyopathy, CK-3773274, oHCM

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CK-3773274 for Single Ascending Dose (SAD) Cohorts

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo comparator for SAD Cohorts

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

CK-3773274 for Multiple Dose (MD) Cohort

Arm Type

Experimental

Arm Description

Subjects will receive multiple doses of CK-3773274

Arm Title

Placebo comparator for MD Cohort

Arm Type

Placebo Comparator

Arm Description

Subjects will receive multiple doses of placebo comparator

Intervention Type

Drug

Intervention Name(s)

CK-3773274

Intervention Description

CK-3773274- Tablets

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo- Tablets

Primary Outcome Measure Information:

Title

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

Time Frame

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

Title

Reduced Left Ventricular Ejection Fraction (LVEF)

Time Frame

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

Secondary Outcome Measure Information:

Title

Cmax of CK-3773274 after single and multiple ascending doses

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chen, MD

Organizational Affiliation

Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Site

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100032

Country

China

12. IPD Sharing Statement

Learn more about this trial

Safety, Tolerability and Pharmacokinetics Study of CK-3773274

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