Clinical trial NCT05806359: A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy
Danicamtiv
Japanese
Caucasian
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-04-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Day 1 up to Day 28
measure: Number of Participants with Vital Sign Abnormalities
timeFrame: Day 1 up to Day 7
measure: Number of Participants with Electrocardiogram (ECG) Abnormalities
timeFrame: Day 1 up to Day 7
measure: Number of Participants with Physical Examination Abnormalities
timeFrame: Day 1 up to Day 7
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Day 1 up to Day 7
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Predose and at multiple timepoints (Day 1 up to Day 6) after dosing
measure: Time of Maximum Observed Plasma Concentration (Tmax)
timeFrame: Predose and at multiple timepoints (Day 1 up to Day 6) after dosing
measure: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)]
timeFrame: Predose and at multiple timepoints (Day 1 up to Day 6) after dosing
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: