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A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BMS-986142 200mg

BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin)

BMS-986142 350mg

About this trial

This is an interventional basic science trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Signed Informed Consent
Target population: Healthy (current non-smokers) subjects as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory determinations.
Subjects with body mass index of 18 to 32 kg/m2, inclusive
Men, and women of nonchildbearing potential. Women must have documented proof that they are not of childbearing potential and must not be breastfeeding.
Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of the study drug (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days (approximately 14 weeks) after treatment completion. Female partners of male subjects are expected to use one of the highly effective methods of contraception listed in the protocol.

Exclusion Criteria:

History of any chronic or acute illness, recent infection, gastrointestinal disease, smoking and alcohol abuse, any significant drug allergy or allergy to digoxin, flurbiprofen, midazolam, omeprazole, or montelukast, Bruton's tyrosine kinase (BTK) inhibitors, immunologic or related compounds.
History of billiary disorder, asthma, bleeding disorder, cancer
Received live vaccine during last 12 weeks, active tuberculosis (TB) in last 3 years
Medical history indicative of an increased risk of arrhythmia.
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.

Sites / Locations

Ppd Development, Lp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1 (BMS-986142: 200 mg)

Cohort 2 (BMS-986142: 350 mg)

Arm Description

200mg BMS-986142 administered orally once daily on specified days.

350mg BMS-986142 administered orally once daily on specified days.

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax) of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin.

Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin

Secondary Outcome Measures

Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death

Full Information

NCT ID

NCT02762123

First Posted

May 3, 2016

Last Updated

September 15, 2016

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02762123

Brief Title

A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates

Official Title

Effects of Concomitant Administration of BMS-986142 on the Single-dose Pharmacokinetics of Probe Substrates for CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-gp in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

May 2016 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study is being conducted to assess the effect of BMS-986142 on the single-dose PK parameters of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin, probe drugs for (cytochome P450) CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-glycoprotein (P-gp), respectively.

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

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1 (BMS-986142: 200 mg)

Arm Type

Experimental

Arm Description

200mg BMS-986142 administered orally once daily on specified days.

Arm Title

Cohort 2 (BMS-986142: 350 mg)

Arm Type

Experimental

Arm Description

350mg BMS-986142 administered orally once daily on specified days.

Intervention Type

Drug

Intervention Name(s)

BMS-986142 200mg

Intervention Type

Drug

Intervention Name(s)

BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin)

Intervention Type

Drug

Intervention Name(s)

BMS-986142 350mg

Primary Outcome Measure Information:

Title

Maximum observed plasma concentration (Cmax) of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin.

Time Frame

57 samples up to day 26

Title

Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin

Time Frame

57 samples up to day 26

Title

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin

Time Frame

57 samples up to day 26

Secondary Outcome Measure Information:

Title

Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death

Time Frame

Days 1-26; for SAEs up to 30 days post discontinuation of dosing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed Informed Consent Target population: Healthy (current non-smokers) subjects as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory determinations. Subjects with body mass index of 18 to 32 kg/m2, inclusive Men, and women of nonchildbearing potential. Women must have documented proof that they are not of childbearing potential and must not be breastfeeding. Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of the study drug (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days (approximately 14 weeks) after treatment completion. Female partners of male subjects are expected to use one of the highly effective methods of contraception listed in the protocol. Exclusion Criteria: History of any chronic or acute illness, recent infection, gastrointestinal disease, smoking and alcohol abuse, any significant drug allergy or allergy to digoxin, flurbiprofen, midazolam, omeprazole, or montelukast, Bruton's tyrosine kinase (BTK) inhibitors, immunologic or related compounds. History of billiary disorder, asthma, bleeding disorder, cancer Received live vaccine during last 12 weeks, active tuberculosis (TB) in last 3 years Medical history indicative of an increased risk of arrhythmia. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.

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

Ppd Development, Lp

City

Austin

State/Province

Texas

ZIP/Postal Code

78744

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.bms.com/studyconnect/pages/home.aspx

Description

BMS Clinical Trial Education Resource

URL

http://www.fda.gov/Safety/Recalls/

Description

FDA Safety Alerts and Recalls

Learn more about this trial

A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates

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