NCT02277600

Brief Summary

This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male and female subjects. There is no formal hypothesis, however, it is expected that the coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase the systemic exposure of BMS-626529.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_1

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 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

November 5, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2015

Completed
Last Updated

January 24, 2018

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

October 27, 2014

Last Update Submit

January 22, 2018

Conditions

Infection, Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic parameters (maximum observed plasma concentration and area under the concentration-time curve in 1 dosing interval) for BMS-626529

    In the presence or absence of multiple doses of DRV/COBI or COBI

    predose and up to 12 hours post dose on Days 4 and 14

Other Outcomes (1)

  • Safety as assessed by adverse events and other physical parameters

    From dosing (Day 1) to Day 14

Study Arms (2)

Cohort 1, Treatment A, B

EXPERIMENTAL

Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: BMS-663068 orally BID plus DRV/COBI orally once daily (QD) on Days 5 through 14

Drug: BMS-663068Drug: DarunavirDrug: Cobicistat

Cohort 2, Treatment C, D

EXPERIMENTAL

Treatment C: BMS-663068 orally BID on Days 1 through 4 Treatment D: BMS-663068 orally BID plus COBI QD on Days 5 through 14

Drug: BMS-663068Drug: Cobicistat

Interventions

BMS-663068DRUG

BMS-663068

Cohort 1, Treatment A, BCohort 2, Treatment C, D
DarunavirDRUG

Darunavir

Cohort 1, Treatment A, B
CobicistatDRUG

Cobicistat

Cohort 1, Treatment A, BCohort 2, Treatment C, D

Eligibility Criteria

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

You may qualify if:

  • Healthy male and female
  • Nonsmoking subjects
  • Ages 18 to 50 years
  • Inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive
  • Women of childbearing potential
  • Must agree to follow instructions for methods of contraception for the duration of the study plus 34 days post-treatment completion

You may not qualify if:

  • Any history of acute or chronic medical and surgical illness.
  • Personal of family history of hemophilia A or B

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

  • Moore K, Thakkar N, Magee M, Sevinsky H, Vakkalagadda B, Lubin S, Llamoso C, Ackerman P. Pharmacokinetics of Temsavir, the Active Moiety of the HIV-1 Attachment Inhibitor Prodrug, Fostemsavir, Coadministered with Cobicistat, Etravirine, Darunavir/Cobicistat, or Darunavir/Ritonavir with or without Etravirine in Healthy Participants. Antimicrob Agents Chemother. 2022 Apr 19;66(4):e0225121. doi: 10.1128/aac.02251-21. Epub 2022 Mar 22.

    PMID: 35315687DERIVED

MeSH Terms

Conditions

InfectionsAcquired Immunodeficiency Syndrome

Interventions

fostemsavirDarunavirCobicistat

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsCarbamatesAcids, AcyclicCarboxylic AcidsSulfonesSulfur CompoundsFuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesAzoles

Study Officials

  • GSK Clinical Trials

    ViiV Healthcare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2014

First Posted

October 29, 2014

Study Start

November 5, 2014

Primary Completion

January 12, 2015

Study Completion

January 12, 2015

Last Updated

January 24, 2018

Record last verified: 2017-07

Locations

US(1)