Healthy Volunteers
Conditions
Keywords
Healthy volunteers
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.
Interventions
DRUG[14C] BMS-986278
Specified dose on specified days
DRUGKinevac®
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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/
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Adverse Events (AEs) | Up to 15 days | — |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | Up to 43 days | The QT interval is the time from the start of the Q wave to the end of the T wave. |
| Incidence of clinically significant changes in physical examination findings | Up to 43 days | — |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF | 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. |
| 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 | — |
Countries
United States
Outcome results
None listed