DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)

Open-Label, Single-Sequence Study to Evaluate the Pharmacokinetic Interaction of BMS-663068 With Darunavir/Ritonavir and/or Etravirine in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02063360

Enrollment

Registered

2014-02-14

Start date

2014-02-01

Completion date

2014-05-13

Last updated

2017-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Human Immunodeficiency Virus

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.

Detailed description

Brief title: drug-drug interaction (DDI) Primary Purpose: Other : Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Interventions

DRUGBMS-663068

BMS-663068

DRUGDarunavir (DRV)

Darunavir (DRV)

DRUGRitonavir (RTV)

Ritonavir (RTV)

DRUGEtravirine (ETR)

Etravirine (ETR)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
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)
Safety and tolerability endpoints include incidence of adverse event (AEs), serious adverse event (SAEs), AEs leading to discontinuation, deaths, marked laboratory abnormalities, and abnormalities in vital signs, physical examination, and 12-lead ECGs	Up to day 27
AUC(TAU) for DRV, RTV, and ETR	24 timepoints up to 26 day
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026