NCT02578277

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

November 9, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2015

Completed
Last Updated

July 13, 2018

Status Verified

July 1, 2018

Enrollment Period

1 month

First QC Date

October 15, 2015

Last Update Submit

July 11, 2018

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (3)

  • Cmax (maximum observed concentration)

    Days 1 to 18

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

    Days 1 to 18

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

    Days 1 to 18

Study Arms (1)

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

EXPERIMENTAL

Single sequence

Drug: CYP and transporter probe substratesDrug: BMS-955176Drug: BMS-955176 plus CYP and transporter probe substrates

Interventions

CYP and transporter probe substratesDRUG

Cocktail of CYP (cytochrome P450) and transporter probe substrates

Single sequence, 3-period DDI (drug-drug interaction)
BMS-955176DRUG

BMS-955176

Single sequence, 3-period DDI (drug-drug interaction)
BMS-955176 plus CYP and transporter probe substratesDRUG

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

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

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

BMS-955176

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • GSK Clinical Trials

    ViiV Healthcare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2015

First Posted

October 16, 2015

Study Start

November 9, 2015

Primary Completion

December 23, 2015

Study Completion

December 23, 2015

Last Updated

July 13, 2018

Record last verified: 2018-07

Locations

US(1)