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A Study of BMS-986195 in Healthy Male Subjects

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
BMS-986195
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BMS-986195

Arm Description

A single oral solution dose of BMS-986195

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax)
Time to attain maximum observed plasma concentration (tmax)
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)]
Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Ĉlast/kel [AUC(0-inf)]
Percentage of estimated part for the calculation of AUC0-inf (%AUCextra)
Terminal elimination rate constant (kel)
Terminal elimination half life, calculated as 0.693/kel (t1/2)
Apparent oral clearance, calculated as dose/AUC0-inf (CL/F)
Apparent volume of distribution at terminal phase (Vz/F)
Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%)
Ratio of AUC0-inf of plasma TRA relative to blood TRA (%)
Cumulative amount of TRA excreted in urine (Aeurine)
Cumulative amount of TRA excreted in feces (Aefeces)
Cumulative amount of TRA excreted in bile (Aebile)
Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces
Fraction of the dose administered excreted in urine (feurine)
Fraction of the dose administered excreted in feces (fefeces)
Fraction of the dose administered excreted in bile (febile)
Fraction of the dose administered excreted in urine and feces (fetotal)

Secondary Outcome Measures

Number of adverse events (AE)
Number of serious adverse events (SAE)
Number of laboratory test result abnormalities
Heart rate measured by ECG
PR-interval measured by ECG
QRS-duration measured by ECG
QT-interval measured by ECG
QTc-interval (Fridericia's) measured by ECG

Full Information

First Posted
August 8, 2017
Last Updated
January 3, 2018
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03245515
Brief Title
A Study of BMS-986195 in Healthy Male Subjects
Official Title
Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
September 22, 2017 (Actual)
Study Completion Date
October 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-986195
Arm Type
Experimental
Arm Description
A single oral solution dose of BMS-986195
Intervention Type
Drug
Intervention Name(s)
BMS-986195
Intervention Description
specified dose on specified days
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Up to 16 days
Title
Time to attain maximum observed plasma concentration (tmax)
Time Frame
Up to 16 days
Title
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)]
Time Frame
Up to 16 days
Title
Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Ĉlast/kel [AUC(0-inf)]
Time Frame
Up to 16 days
Title
Percentage of estimated part for the calculation of AUC0-inf (%AUCextra)
Time Frame
Up to 16 days
Title
Terminal elimination rate constant (kel)
Time Frame
Up to 16 days
Title
Terminal elimination half life, calculated as 0.693/kel (t1/2)
Time Frame
Up to 16 days
Title
Apparent oral clearance, calculated as dose/AUC0-inf (CL/F)
Time Frame
Up to 16 days
Title
Apparent volume of distribution at terminal phase (Vz/F)
Time Frame
Up to 16 days
Title
Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%)
Time Frame
Up to 16 days
Title
Ratio of AUC0-inf of plasma TRA relative to blood TRA (%)
Time Frame
Up to 16 days
Title
Cumulative amount of TRA excreted in urine (Aeurine)
Time Frame
Up to 16 days
Title
Cumulative amount of TRA excreted in feces (Aefeces)
Time Frame
Up to 16 days
Title
Cumulative amount of TRA excreted in bile (Aebile)
Time Frame
Up to 16 days
Title
Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces
Time Frame
Up to 16 days
Title
Fraction of the dose administered excreted in urine (feurine)
Time Frame
Up to 16 days
Title
Fraction of the dose administered excreted in feces (fefeces)
Time Frame
Up to 16 days
Title
Fraction of the dose administered excreted in bile (febile)
Time Frame
Up to 16 days
Title
Fraction of the dose administered excreted in urine and feces (fetotal)
Time Frame
Up to 16 days
Secondary Outcome Measure Information:
Title
Number of adverse events (AE)
Time Frame
Up to 16 days
Title
Number of serious adverse events (SAE)
Time Frame
Up to 16 days
Title
Number of laboratory test result abnormalities
Time Frame
Up to 16 days
Title
Heart rate measured by ECG
Time Frame
Up to 16 days
Title
PR-interval measured by ECG
Time Frame
Up to 16 days
Title
QRS-duration measured by ECG
Time Frame
Up to 16 days
Title
QT-interval measured by ECG
Time Frame
Up to 16 days
Title
QTc-interval (Fridericia's) measured by ECG
Time Frame
Up to 16 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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/exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Groningen
ZIP/Postal Code
9728 NZ
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

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A Study of BMS-986195 in Healthy Male Subjects

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