A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Danicamtiv in Healthy Japanese and Caucasian Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05806359
• Other study ID #: CV028-1001
• Status: Completed
• Phase: Phase 1
• Start date: March 31, 2023
• Est. completion date: August 14, 2023

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability, and single-dose pharmacokinetics of danicamtiv in healthy Japanese and Caucasian participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body mass index between 18 and 30 kilograms/meter squared inclusive, at the screening visit.

• Japanese participants must be of Japanese descent (both biological parents are ethnically Japanese).

• Caucasian participants must be of European or Latin American Caucasian descent.

• A female participant is eligible to participate if she is a woman of nonchildbearing potential as defined in the protocol.

• Males who are sexually active with woman of childbearing potential must agree to follow protocol-defined instructions for method(s) of contraception.

Exclusion Criteria:

• Any acute or chronic medical illness.

• Active infection, including with coronavirus disease-19, diagnosed clinically by the investigator.

• History of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or sponsor clinical trial physician, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Danicamtiv
Specified dose on specified days
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs)		Day 1 up to Day 28
Primary	Number of Participants with Vital Sign Abnormalities		Day 1 up to Day 7
Primary	Number of Participants with Electrocardiogram (ECG) Abnormalities		Day 1 up to Day 7
Primary	Number of Participants with Physical Examination Abnormalities		Day 1 up to Day 7
Primary	Number of Participants with Clinical Laboratory Abnormalities		Day 1 up to Day 7
Secondary	Maximum Observed Plasma Concentration (Cmax)		Predose and at multiple timepoints (Day 1 up to Day 6) after dosing
Secondary	Time of Maximum Observed Plasma Concentration (Tmax)		Predose and at multiple timepoints (Day 1 up to Day 6) after dosing
Secondary	Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)]		Predose and at multiple timepoints (Day 1 up to Day 6) after dosing

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting