NCT02063360

Brief Summary

The purpose of this study is to determine if there is an interaction in healthy subjects taking BMS-663068 with Darunavir/Ritonavir and/or Etravirine.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

February 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2014

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

February 13, 2014

Last Update Submit

August 7, 2017

Conditions

Infection, Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (2)

  • Maximum observed plasma concentration (Cmax) of BMS-626529

    20 timepoints up to day 26

  • Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of BMS-626529

    20 timepoints up to day 26

Secondary Outcomes (6)

  • Time of maximum observed plasma concentration (Tmax) for BMS-626529, DRV, RTV, and ETR

    Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)

  • Concentration at 12 hours (C12) for BMS-626529, DRV, RTV, and ETR

    Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)

  • Trough observed plasma concentration (Ctrough) for BMS-626529, DRV, RTV, and ETR

    Up to day 26 (20 timepoints for BMS-626529, 24 timepoints for DRV, RTV and ETR)

  • Cmax for DRV, RTV, and ETR

    24 timepoints up to 26 day

  • AUC(TAU) for DRV, RTV, and ETR

    24 timepoints up to 26 day

  • +1 more secondary outcomes

Study Arms (3)

Cohort 1: BMS-663068+DRV/RTV

EXPERIMENTAL

Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg orally orally twice daily on days 7-16

Drug: BMS-663068Drug: Darunavir (DRV)Drug: Ritonavir (RTV)

Cohort 2: BMS-663068+ETR

EXPERIMENTAL

Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet ETR 200mg orally orally twice daily on days 7-16

Drug: BMS-663068Drug: Etravirine (ETR)

Cohort 3: BMS-663068+DRV/RTV+ETR

EXPERIMENTAL

Extended release tablet BMS-663068 600mg orally twice daily on days 1-4 and 17-26. Tablet DRV 600mg / RTV 100mg and ETR 200mg orally orally twice daily on days 7-16

Drug: BMS-663068Drug: Darunavir (DRV)Drug: Ritonavir (RTV)Drug: Etravirine (ETR)

Interventions

BMS-663068DRUG

BMS-663068

Cohort 1: BMS-663068+DRV/RTVCohort 2: BMS-663068+ETRCohort 3: BMS-663068+DRV/RTV+ETR
Darunavir (DRV)DRUG

Darunavir (DRV)

Also known as: Prezista
Cohort 1: BMS-663068+DRV/RTVCohort 3: BMS-663068+DRV/RTV+ETR
Ritonavir (RTV)DRUG

Ritonavir (RTV)

Also known as: Norvir
Cohort 1: BMS-663068+DRV/RTVCohort 3: BMS-663068+DRV/RTV+ETR
Etravirine (ETR)DRUG

Etravirine (ETR)

Also known as: Intelence
Cohort 2: BMS-663068+ETRCohort 3: BMS-663068+DRV/RTV+ETR

Eligibility Criteria

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

You may qualify if:

  • Healthy subjects with no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory tests
  • Women of childbearing potential (WOCBP) allowed. Must be practicing highly effective methods of contraception

You may not qualify if:

  • Any significant acute or chronic medical condition
  • Unable to tolerate oral medications
  • Inability to be venipunctured and/or tolerate venous access
  • Current or recent (within 3 months of dosing) gastrointestinal disease
  • Abnormal liver function test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

fostemsavirDarunavirRitonaviretravirine

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
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 14, 2014

Study Start

February 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 13, 2014

Last Updated

August 8, 2017

Record last verified: 2017-08