A Study of BMS-986195 in Healthy Male Subjects
Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects
2 other identifiers
interventional
24
1 country
1
Brief Summary
The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 rheumatoid-arthritis
Started Aug 2017
Shorter than P25 for phase_1 rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2017
CompletedFirst Posted
Study publicly available on registry
August 10, 2017
CompletedStudy Start
First participant enrolled
August 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2017
CompletedJanuary 5, 2018
January 1, 2018
1 month
August 8, 2017
January 3, 2018
Conditions
Outcome Measures
Primary Outcomes (19)
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
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
Fraction of the dose administered excreted in urine and feces (fetotal)
Up to 16 days
Secondary Outcomes (8)
Number of adverse events (AE)
Up to 16 days
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
- +3 more secondary outcomes
Study Arms (1)
BMS-986195
EXPERIMENTALA single oral solution dose of BMS-986195
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Groningen, 9728 NZ, Netherlands
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2017
First Posted
August 10, 2017
Study Start
August 15, 2017
Primary Completion
September 22, 2017
Study Completion
October 5, 2017
Last Updated
January 5, 2018
Record last verified: 2018-01