NCT06433505

Brief Summary

The objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started May 2024

Typical duration 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

May 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

May 30, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

May 23, 2024

Last Update Submit

March 25, 2025

Conditions

Healthy Volunteers

Keywords

BMS-986365PharmacokineticsAbsolute BioavailabilityHealthy Male VolunteersCC-94676ADME

Outcome Measures

Primary Outcomes (11)

  • Maximum observed concentration (Cmax)

    Part A and B

    Up to Day 60

  • Time of maximum observed concentration (Tmax)

    Part A and B

    Up to Day 60

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

    Part A and B

    Up to Day 60

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

    Part A and B

    Up to Day 60

  • Apparent terminal plasma half-life (T-HALF)

    Part A and B

    Up to Day 60

  • Total body clearance (CLT)

    Part A

    Up to Day 15

  • Apparent total body clearance (CLT/F)

    Part A and B

    Up to Day 60

  • Mean residence time (MRT)

    Part A

    Up to Day 15

  • Apparent volume of distribution (Vz)

    Part A

    Up to Day 15

  • Apparent volume of distribution (Vz/F)

    Part A and B

    Up to Day 60

  • Absolute bioavailability (F)

    Part A

    Up to Day 15

Secondary Outcomes (7)

  • Number of participants with Adverse Events

    Up to Day 60

  • Number of participants with Serious Adverse Events

    Up to Day 60

  • Number of participants with AEs leading to discontinuation

    Up to Day 60

  • Number of participants with Vital sign abnormalities

    Up to Day 60

  • Number of participants with electrocardiogram (ECG) abnormalities

    Up to Day 60

  • +2 more secondary outcomes

Study Arms (3)

Part A

EXPERIMENTAL
Drug: BMS-986365Drug: [14C] BMS-986365

Part B - Arm 1

EXPERIMENTAL
Drug: [14C] BMS-986409 + BMS-986410

Part B - Arm 2

EXPERIMENTAL
Drug: [14C] BMS-986410 + BMS-986409

Interventions

BMS-986365DRUG

Specified dose on specified days

Part A
[14C] BMS-986365DRUG

Specified dose on specified days.

Part A
[14C] BMS-986409 + BMS-986410DRUG

Specified dose on specified days

Part B - Arm 1
[14C] BMS-986410 + BMS-986409DRUG

Specified dose on specified days

Part B - Arm 2

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations, as determined by the investigator
  • Participants will require a left ventricular ejection fraction of \> 50% at screening.
  • Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening. Body mass index = weight(kg)/(height \[m\])2.

You may not qualify if:

  • Any current or recent significant acute or chronic illness.
  • Participants with a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QTcF interval (\> 450 ms) at screening.
  • History of allergy to BMS-986365 or related compounds.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution - 0001

Madison, Wisconsin, 53704, United States

Location

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 23, 2024

First Posted

May 29, 2024

Study Start

May 30, 2024

Primary Completion

February 14, 2025

Study Completion

February 28, 2025

Last Updated

March 26, 2025

Record last verified: 2025-03

Locations

US(1)