Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.
Interventions
DRUGBMS-986195
specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fraction of the dose administered excreted in urine and feces (fetotal) | Up to 16 days |
| Ratio of AUC0-inf of plasma TRA relative to blood TRA (%) | Up to 16 days |
| Cumulative amount of TRA excreted in urine (Aeurine) | Up to 16 days |
| Cumulative amount of TRA excreted in feces (Aefeces) | Up to 16 days |
| Cumulative amount of TRA excreted in bile (Aebile) | Up to 16 days |
| Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces | Up to 16 days |
| Fraction of the dose administered excreted in urine (feurine) | Up to 16 days |
| Fraction of the dose administered excreted in feces (fefeces) | Up to 16 days |
| Fraction of the dose administered excreted in bile (febile) | Up to 16 days |
| Maximum observed plasma concentration (Cmax) | 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 |
| 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 |
| Percentage of estimated part for the calculation of AUC0-inf (%AUCextra) | Up to 16 days |
| Terminal elimination rate constant (kel) | Up to 16 days |
| Terminal elimination half life, calculated as 0.693/kel (t1/2) | Up to 16 days |
| Apparent oral clearance, calculated as dose/AUC0-inf (CL/F) | Up to 16 days |
| Apparent volume of distribution at terminal phase (Vz/F) | Up to 16 days |
| Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%) | Up to 16 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of serious adverse events (SAE) | Up to 16 days |
| Number of laboratory test result abnormalities | Up to 16 days |
| Heart rate measured by ECG | Up to 16 days |
| PR-interval measured by ECG | Up to 16 days |
| QRS-duration measured by ECG | Up to 16 days |
| QT-interval measured by ECG | Up to 16 days |
| QTc-interval (Fridericia's) measured by ECG | Up to 16 days |
| Number of adverse events (AE) | Up to 16 days |
Countries
Netherlands
Outcome results
None listed