A Study of BMS-986195 in Healthy Male Subjects
- Registration Number
- NCT03245515
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- Male subjects, if not surgically sterilized, must agree to use adequate contraception
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive (BMI = weight [kg]/[height (m)]2), and total body weight >50 kg
- All prescribed medication, including live vaccinations, must have been stopped at least 30 days prior to admission to the clinical research center
- All over-the-counter (OTC ) medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research center
- Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit (juice) from 3 days prior to admission to the clinical research center
- Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the Principal Investigator
Exclusion Criteria
- Previous participation in the current study
- Known previous exposure to BMS-986195
- Employee of PRA or the Sponsor
- History of relevant drug and/or food allergies, including allergy to immunologic or related compounds or allergy to seafood or marine products
- Using tobacco products within 60 days prior to drug administration
- Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies
Other protocol defined inclusion/exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BMS-986195 BMS-986195 A single oral solution dose of BMS-986195
- Primary Outcome Measures
Name Time Method Ratio of AUC0-inf of plasma TRA relative to blood TRA (%) Up to 16 days Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces Up to 16 days Percentage of estimated part for the calculation of AUC0-inf (%AUCextra) Up to 16 days Apparent oral clearance, calculated as dose/AUC0-inf (CL/F) Up to 16 days Cumulative amount of TRA excreted in feces (Aefeces) Up to 16 days Fraction of the dose administered excreted in urine (feurine) Up to 16 days Maximum observed plasma concentration (Cmax) Up to 16 days Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Ĉlast/kel [AUC(0-inf)] Up to 16 days Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%) Up to 16 days Cumulative amount of TRA excreted in bile (Aebile) Up to 16 days Fraction of the dose administered excreted in feces (fefeces) Up to 16 days Fraction of the dose administered excreted in urine and feces (fetotal) Up to 16 days Terminal elimination rate constant (kel) Up to 16 days Fraction of the dose administered excreted in bile (febile) Up to 16 days Time to attain maximum observed plasma concentration (tmax) Up to 16 days Area under the plasma concentration-time curve up to time t, where t is the last point with concentrations above the lower limit of quantitation [AUC(t-0)] Up to 16 days Terminal elimination half life, calculated as 0.693/kel (t1/2) Up to 16 days Apparent volume of distribution at terminal phase (Vz/F) Up to 16 days Cumulative amount of TRA excreted in urine (Aeurine) Up to 16 days
- Secondary Outcome Measures
Name Time Method QTc-interval (Fridericia's) measured by ECG Up to 16 days Number of serious adverse events (SAE) Up to 16 days Number of laboratory test result abnormalities Up to 16 days PR-interval measured by ECG Up to 16 days QT-interval measured by ECG Up to 16 days Number of adverse events (AE) Up to 16 days QRS-duration measured by ECG Up to 16 days Heart rate measured by ECG Up to 16 days
Trial Locations
- Locations (1)
Local Institution
🇳🇱Groningen, Netherlands