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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04567667
• Other study ID #: IM027-048
• Status: Completed
• Phase: Phase 1
• Start date: October 15, 2020
• Est. completion date: April 11, 2021

Study information

• Verified date: June 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 11, 2021
• Est. primary completion date: April 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C] BMS-986278
Specified dose on specified days
• Kinevac®
Specified dose on specified days

Locations

Country	Name	City	State
United States	Covance - Clinical Pharmacology Services - Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of BMS-986278		Up to 15 days
Primary	Maximum observed plasma concentration (Cmax) of total radioactivity (TRA)		Up to 15 days
Primary	Time of maximum observed plasma concentration (Tmax) of BMS-986278		Up to 15 days
Primary	Time of maximum observed plasma concentration (Tmax) of TRA		Up to 15 days
Primary	Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of BMS-986278		Up to 15 days
Primary	Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of TRA		Up to 15 days
Secondary	Incidence of Adverse Events (AEs)		Up to 15 days
Secondary	Incidence of Serious Adverse Events (AEs)		Up to 73 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 43 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to 43 days
Secondary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 43 days
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 43 days
Secondary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 43 days
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 43 days
Secondary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 43 days
Secondary	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
Secondary	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
Secondary	Incidence of clinically significant changes in physical examination findings		Up to 43 days

External Links

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