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

NCT05806359 | Completed Phase 1 FDA Drug

• 1 other identifier: CV028-1001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Healthy; Danicamtiv; Japanese; Caucasian

Outcome Measures

Primary Outcomes (5)

• Number of Participants with Adverse Events (AEs)

  Day 1 up to Day 28

• Number of Participants with Vital Sign Abnormalities

  Day 1 up to Day 7

• Number of Participants with Electrocardiogram (ECG) Abnormalities

  Day 1 up to Day 7

• Number of Participants with Physical Examination Abnormalities

  Day 1 up to Day 7

• Number of Participants with Clinical Laboratory Abnormalities

  Day 1 up to Day 7

Secondary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax)

  Predose and at multiple timepoints (Day 1 up to Day 6) after dosing

• Time of Maximum Observed Plasma Concentration (Tmax)

  Predose and at multiple timepoints (Day 1 up to Day 6) after dosing

• 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

Study Arms (4)

Japanese Cohort - Dose 1

EXPERIMENTAL

Drug: Danicamtiv; Drug: Placebo

Japanese Cohort - Dose 2

EXPERIMENTAL

Drug: Danicamtiv; Drug: Placebo

Japanese Cohort - Dose 3

EXPERIMENTAL

Drug: Danicamtiv; Drug: Placebo

Caucasian Cohort - Dose 3

EXPERIMENTAL

Drug: Danicamtiv; Drug: Placebo

Interventions

Danicamtiv DRUG

Specified dose on specified days

Also known as: BMS-986434, MYK-491

Caucasian Cohort - Dose 3; Japanese Cohort - Dose 1; Japanese Cohort - Dose 2; Japanese Cohort - Dose 3

Placebo DRUG

Specified dose on specified days

Caucasian Cohort - Dose 3; Japanese Cohort - Dose 1; Japanese Cohort - Dose 2; Japanese Cohort - Dose 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 10, 2023
• Study Start: March 31, 2023
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

US (1)