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

Infection, Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063360
• Other study ID #: 206281
• Secondary ID: AI438-020
• Status: Completed
• Phase: Phase 1
• First received: February 13, 2014
• Last updated: August 7, 2017
• Start date: February 1, 2014
• Est. completion date: May 13, 2014

Study information

• Verified date: August 2017
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Brief title: drug-drug interaction (DDI)

Primary Purpose: Other : Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 13, 2014
• Est. primary completion date: May 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection, Human Immunodeficiency Virus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of BMS-626529		20 timepoints up to day 26
Primary	Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of BMS-626529		20 timepoints up to day 26
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Cmax for DRV, RTV, and ETR		24 timepoints up to 26 day
Secondary	AUC(TAU) for DRV, RTV, and ETR		24 timepoints up to 26 day
Secondary	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