NCT06027437

Brief Summary

The purpose of this study is to assess the relative biological availability and the effect of food on the drug levels of Danicamtiv in health adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2023

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

August 31, 2023

Last Update Submit

November 27, 2023

Conditions

Healthy Volunteers

Keywords

BMS-986434MYK-491HealthyBiological AvailabilityFood Effect

Outcome Measures

Primary Outcomes (3)

  • Maximum observed plasma concentration (Cmax)

    Up to day 16

  • Area under the plasma concentration time curve from time zero extrapolated to infinite time (AUC(INF))

    Up to day 16

  • Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))

    Up to day 16

Secondary Outcomes (10)

  • Time of maximum observed plasma concentration (Tmax)

    Up to day 16

  • Terminal elimination half-life (T-HALF)

    Up to day 16

  • Apparent total body clearance (CLT/F)

    Up to day 16

  • Apparent volume of distribution (Vz/F)

    Up to day 16

  • Number of participants with Adverse Events (AEs)

    Up to day 43

  • +5 more secondary outcomes

Study Arms (3)

Treatment A

EXPERIMENTAL
Drug: Danicamtiv

Treatment B

EXPERIMENTAL
Drug: Danicamtiv

Treatment C

EXPERIMENTAL
Drug: Danicamtiv

Interventions

DanicamtivDRUG

Specified dose on specified days.

Also known as: BMS-986434, MYK-491
Treatment ATreatment BTreatment C

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 inclusive
  • Participants with resting heart rate ≥ 55 bpm
  • Seasonal allergies that do not require medication at the time of the study are acceptable

You may not qualify if:

  • Any acute or chronic medical illness
  • Head injury, intracranial tumor, or aneurysm within 2 years prior to screening
  • History of chronic gastrointestinal disorders or gastrointestinal (GI) surgery (including cholecystectomy) that could impact on drug and food absorption and/or drug excretion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 7, 2023

Study Start

September 5, 2023

Primary Completion

November 10, 2023

Study Completion

November 10, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

US(1)