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A Study of BMS-986195 in Healthy Male Subjects

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03245515
Collaborator
(none)
24
Enrollment
1
Location
1
Arm
1.7
Actual Duration (Months)
14.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects
Actual Study Start Date :
Aug 15, 2017
Actual Primary Completion Date :
Sep 22, 2017
Actual Study Completion Date :
Oct 5, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: BMS-986195

A single oral solution dose of BMS-986195

Drug: BMS-986195
specified dose on specified days

Outcome Measures

Primary Outcome Measures

  1. Maximum observed plasma concentration (Cmax) [Up to 16 days]

  2. Time to attain maximum observed plasma concentration (tmax) [Up to 16 days]

  3. 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]

  4. 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]

  5. Percentage of estimated part for the calculation of AUC0-inf (%AUCextra) [Up to 16 days]

  6. Terminal elimination rate constant (kel) [Up to 16 days]

  7. Terminal elimination half life, calculated as 0.693/kel (t1/2) [Up to 16 days]

  8. Apparent oral clearance, calculated as dose/AUC0-inf (CL/F) [Up to 16 days]

  9. Apparent volume of distribution at terminal phase (Vz/F) [Up to 16 days]

  10. Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%) [Up to 16 days]

  11. Ratio of AUC0-inf of plasma TRA relative to blood TRA (%) [Up to 16 days]

  12. Cumulative amount of TRA excreted in urine (Aeurine) [Up to 16 days]

  13. Cumulative amount of TRA excreted in feces (Aefeces) [Up to 16 days]

  14. Cumulative amount of TRA excreted in bile (Aebile) [Up to 16 days]

  15. Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces [Up to 16 days]

  16. Fraction of the dose administered excreted in urine (feurine) [Up to 16 days]

  17. Fraction of the dose administered excreted in feces (fefeces) [Up to 16 days]

  18. Fraction of the dose administered excreted in bile (febile) [Up to 16 days]

  19. Fraction of the dose administered excreted in urine and feces (fetotal) [Up to 16 days]

Secondary Outcome Measures

  1. Number of adverse events (AE) [Up to 16 days]

  2. Number of serious adverse events (SAE) [Up to 16 days]

  3. Number of laboratory test result abnormalities [Up to 16 days]

  4. Heart rate measured by ECG [Up to 16 days]

  5. PR-interval measured by ECG [Up to 16 days]

  6. QRS-duration measured by ECG [Up to 16 days]

  7. QT-interval measured by ECG [Up to 16 days]

  8. QTc-interval (Fridericia's) measured by ECG [Up to 16 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes

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/exclusion criteria could apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Local Institution Groningen Netherlands 9728 NZ

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03245515
Other Study ID Numbers:
  • IM014-016
  • 2017-002706-12
First Posted:
Aug 10, 2017
Last Update Posted:
Jan 5, 2018
Last Verified:
Jan 1, 2018
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Branebrutinib

Study Results

No Results Posted as of Jan 5, 2018