Back to results

Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CYP and transporter probe substrates

BMS-955176

BMS-955176 plus CYP and transporter probe substrates

About this trial

This is an interventional other trial for HIV Infections

Eligibility Criteria

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

Inclusion Criteria:

Written Informed Consent
Healthy male and female (not of childbearing potential) subjects as determined by medical history, surgical history, physical examination, vital signs, ECGs, and clinical laboratory determinations
Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening and Day 1. BMI = weight (kg)/[height(m)]
Women must have documented proof that they are not of childbearing potential (eg, surgically sterile, postmenopausal with a documented follicle-stimulating hormone (FSH) > 40 mIU/mL) and should not be breast feeding
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period

Exclusion Criteria:

Any significant acute or chronic medical illness
Use of tobacco, excessive alcohol
Medical history indicative of an increased risk of a cardiac arrhythmia or cardiac disease and history of asthma, bronchospasm, sleep apnea, rhabdomyolysis, a bleeding disorder, a major depressive disorder within the past 6 months, peptic ulcer or significant GI bleed, Raynaud's disease, or any gastrointestinal surgery that could impact upon the absorption of study drug
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
History of allergy to BMS-955176, digoxin (or any member of the digitalis glycosides class of drugs), caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, or pravastatin, or to any related compounds

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single sequence, 3-period DDI (drug-drug interaction)

Arm Description

Single sequence

Outcomes

Primary Outcome Measures

Cmax (maximum observed concentration)

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

AUC(INF), area under the concentration-time curve from time zero extrapolated to infinite time

Secondary Outcome Measures

Full Information

NCT ID

NCT02578277

First Posted

October 15, 2015

Last Updated

July 11, 2018

Sponsor

ViiV Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT02578277

Brief Title

Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates

Official Title

Effects of BMS-955176 on the Single-dose Pharmacokinetics of Probe Substrates (Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin) in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

November 9, 2015 (Actual)

Primary Completion Date

December 23, 2015 (Actual)

Study Completion Date

December 23, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ViiV Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to study the effects of BMS-955176 on the single-dose PK parameters of probe substrates caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin

6. Conditions and Keywords

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

HIV Infections

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single sequence, 3-period DDI (drug-drug interaction)

Arm Type

Experimental

Arm Description

Single sequence

Intervention Type

Drug

Intervention Name(s)

CYP and transporter probe substrates

Intervention Description

Cocktail of CYP (cytochrome P450) and transporter probe substrates

Intervention Type

Drug

Intervention Name(s)

BMS-955176

Intervention Description

BMS-955176

Intervention Type

Drug

Intervention Name(s)

BMS-955176 plus CYP and transporter probe substrates

Intervention Description

BMS-955176 plus the cocktail of CYP and transporter probe substrates

Primary Outcome Measure Information:

Title

Cmax (maximum observed concentration)

Time Frame

Days 1 to 18

Title

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

Time Frame

Days 1 to 18

Title

AUC(INF), area under the concentration-time curve from time zero extrapolated to infinite time

Time Frame

Days 1 to 18

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: Written Informed Consent Healthy male and female (not of childbearing potential) subjects as determined by medical history, surgical history, physical examination, vital signs, ECGs, and clinical laboratory determinations Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening and Day 1. BMI = weight (kg)/[height(m)] Women must have documented proof that they are not of childbearing potential (eg, surgically sterile, postmenopausal with a documented follicle-stimulating hormone (FSH) > 40 mIU/mL) and should not be breast feeding Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period Exclusion Criteria: Any significant acute or chronic medical illness Use of tobacco, excessive alcohol Medical history indicative of an increased risk of a cardiac arrhythmia or cardiac disease and history of asthma, bronchospasm, sleep apnea, rhabdomyolysis, a bleeding disorder, a major depressive disorder within the past 6 months, peptic ulcer or significant GI bleed, Raynaud's disease, or any gastrointestinal surgery that could impact upon the absorption of study drug 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 History of allergy to BMS-955176, digoxin (or any member of the digitalis glycosides class of drugs), caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, or pravastatin, or to any related compounds

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

ViiV Healthcare

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78744

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates

We'll reach out to this number within 24 hrs