NCT04567667

Brief Summary

The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986278 as well as the safety and tolerability of BMS-986278 in healthy male participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2020

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

September 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2021

Completed
Last Updated

June 2, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

September 24, 2020

Last Update Submit

June 1, 2022

Conditions

Healthy Volunteers

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (6)

  • Maximum observed plasma concentration (Cmax) of BMS-986278

    Up to 15 days

  • Maximum observed plasma concentration (Cmax) of total radioactivity (TRA)

    Up to 15 days

  • Time of maximum observed plasma concentration (Tmax) of BMS-986278

    Up to 15 days

  • Time of maximum observed plasma concentration (Tmax) of TRA

    Up to 15 days

  • Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of BMS-986278

    Up to 15 days

  • Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of TRA

    Up to 15 days

Secondary Outcomes (12)

  • Incidence of Adverse Events (AEs)

    Up to 15 days

  • Incidence of Serious Adverse Events (AEs)

    Up to 73 days

  • Incidence of clinically significant changes in clinical laboratory results: Hematology tests

    Up to 43 days

  • Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

    Up to 43 days

  • Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

    Up to 43 days

  • +7 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL
Drug: [14C] BMS-986278

Group 2

EXPERIMENTAL
Drug: [14C] BMS-986278Drug: Kinevac®

Interventions

[14C] BMS-986278DRUG

Specified dose on specified days

Group 1Group 2
Kinevac®DRUG

Specified dose on specified days

Also known as: Sincalide
Group 2

Eligibility Criteria

Age21 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), vital signs, and clinical laboratory determinations
  • Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb), at screening. BMI = weight (kg)/(height \[m\])2
  • Males must agree to follow specific methods of contraception, if applicable

You may not qualify if:

  • Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
  • Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment
  • Any major surgery within 6 weeks of study treatment administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance - Clinical Pharmacology Services - Madison

Madison, Wisconsin, 53704, United States

Location

Related Links

MeSH Terms

Interventions

Sincalide

Intervention Hierarchy (Ancestors)

CholecystokininGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2020

First Posted

September 28, 2020

Study Start

October 15, 2020

Primary Completion

April 11, 2021

Study Completion

April 11, 2021

Last Updated

June 2, 2022

Record last verified: 2022-06

Locations

US(1)