DRUG
[14C] BMS-986278
Specified dose on specified days
Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 in Healthy Male Participants
Status
Completed
Phase
Phase 1
Enrollment
9
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Kinevac®
Specified dose on specified days
Timeline
From registration to results.
First posted
Sep 28, 2020
Study start
Oct 15, 2020
Primary completion
Apr 11, 2021
Study completion
Apr 11, 2021
Results posted
Not reported
Registry updated
Jun 2, 2022
Outcomes
What the study measures.
Primary outcomes
Maximum observed plasma concentration (Cmax) of BMS-986278
Time frame · Up to 15 days
Maximum observed plasma concentration (Cmax) of total radioactivity (TRA)
Time frame · Up to 15 days
Time of maximum observed plasma concentration (Tmax) of BMS-986278
Time frame · Up to 15 days
Time of maximum observed plasma concentration (Tmax) of TRA
Time frame · Up to 15 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of BMS-986278
Time frame · Up to 15 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of TRA
Time frame · Up to 15 days
Secondary outcomes
Incidence of Adverse Events (AEs)
Time frame · Up to 15 days
Incidence of Serious Adverse Events (AEs)
Time frame · Up to 73 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame · Up to 43 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame · Up to 43 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame · Up to 43 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame · Up to 43 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame · Up to 43 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame · Up to 43 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame · Up to 43 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF
Time frame · Up to 43 days
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.
Eligibility
Who can take part.
- Minimum age
- 21 Years
- Maximum age
- 65 Years
- Sex
- MALE
- Healthy volunteers
- Yes
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 locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Covance - Clinical Pharmacology Services - Madison
Madison, Wisconsin, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.