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A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects

Primary Purpose

Thrombosis

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

BMS-986177

Rifampin

About this trial

This is an interventional basic science trial for Thrombosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Signed Informed Consent
Healthy men and women (not of child bearing potential) as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters.
Subjects with body mass index of 18 to 30 kg/m2, inclusive and with normal kidney function.
Women participants must have documented proof that they are not of childbearing potential.
Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986177 plus 5 half-lives (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days after completion of BMS-986177 treatment.

Exclusion Criteria:

Any significant acute or chronic medical illness, including any other condition listed as a contraindication in the rifampin package insert
History of recurrent headaches, dizziness, chronic diarrhea, gastroesophageal reflux disease, dyspepsia, gastrointestinal ulcer disease, recurrent urinary tract infections, hypermenorrhea and recurrent candida infections, abnormal bleeding, history of hemophilia, Rosenthal syndrome, FXIa deficiency, or other coagulopathies.
Recent surgery, head injury, blood transfusion, systemic lupus erythamatous, aneurysm, drug or alcohol abuse and use of tobacco or nicotine containing products in past six months.
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population
History of allergy to BMS-986177, FXIa inhibitors , rifampin or related compounds

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BMS-986177 and Rifampin

Arm Description

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax)

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))

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

NCT02959060

First Posted

November 7, 2016

Last Updated

January 5, 2017

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02959060

Brief Title

A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects

Official Title

An Open-Label, Single-Sequence Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

November 2016 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 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

This study is to evaluate the effect of rifampin on the single-dose pharmacokinetics (PK) of BMS-986177 in healthy participants with parameters like Cmax, AUC(INF), AUC(0-T)

6. Conditions and Keywords

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

Thrombosis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BMS-986177 and Rifampin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BMS-986177

Intervention Description

Single dose of BMS-986177 and multiple doses of Rifampin

Intervention Type

Drug

Intervention Name(s)

Rifampin

Intervention Description

Single dose of BMS-986177 and multiple doses of Rifampin

Primary Outcome Measure Information:

Title

Maximum observed plasma concentration (Cmax)

Time Frame

Days1-15

Title

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

Time Frame

Days1-15

Title

Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))

Time Frame

Days1-15

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

Screening- until 30 days after discontinuation of dosing or subject's participation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed Informed Consent Healthy men and women (not of child bearing potential) as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters. Subjects with body mass index of 18 to 30 kg/m2, inclusive and with normal kidney function. Women participants must have documented proof that they are not of childbearing potential. Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986177 plus 5 half-lives (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days after completion of BMS-986177 treatment. Exclusion Criteria: Any significant acute or chronic medical illness, including any other condition listed as a contraindication in the rifampin package insert History of recurrent headaches, dizziness, chronic diarrhea, gastroesophageal reflux disease, dyspepsia, gastrointestinal ulcer disease, recurrent urinary tract infections, hypermenorrhea and recurrent candida infections, abnormal bleeding, history of hemophilia, Rosenthal syndrome, FXIa deficiency, or other coagulopathies. Recent surgery, head injury, blood transfusion, systemic lupus erythamatous, aneurysm, drug or alcohol abuse and use of tobacco or nicotine containing products in past six months. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population History of allergy to BMS-986177, FXIa inhibitors , rifampin or related compounds

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

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 Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects

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