Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 in Healthy Male Participants

Pharmacokinetics and Metabolism of [14C] BMS-986278 in Healthy Male Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [14C] BMS-986278; Drug: Kinevac®

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance - Clinical Pharmacology Services - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 2	Drug: [14C] BMS-986278; Specified dose on specified days; Drug: Kinevac®; Specified dose on specified days; Other Names: Sincalide
Experimental: Group 1	Drug: [14C] BMS-986278; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence of clinically significant changes in vital signs: Blood pressure		Up to 43 days
Incidence of clinically significant changes in vital signs: Heart rate		Up to 43 days
Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 43 days
Incidence of clinically significant changes in vital signs: Body temperature		Up to 43 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF	QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave.	Up to 43 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval	The QT interval is the time from the start of the Q wave to the end of the T wave.	Up to 43 days
Incidence of clinically significant changes in physical examination findings		Up to 43 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): April 11, 2021
• Study Completion (Actual): April 11, 2021

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Healthy volunteers
• Other Study ID Numbers: IM027-048

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No