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Completed

NCT Number: NCT02063360

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

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.

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Key information

Conditions

Infection, Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

Brief title: drug-drug interaction (DDI)

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-663068

Drug

BMS-663068

Darunavir (DRV)

Drug

Darunavir (DRV)

Other names: Prezista

Ritonavir (RTV)

Drug

Ritonavir (RTV)

Other names: Norvir

Etravirine (ETR)

Drug

Etravirine (ETR)

Other names: Intelence

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of BMS-626529

    Time frame: 20 timepoints up to day 26

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

    Time frame: 20 timepoints up to day 26

Secondary outcomes

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

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

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

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

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

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

  4. Cmax for DRV, RTV, and ETR

    Time frame: 24 timepoints up to 26 day

  5. AUC(TAU) for DRV, RTV, and ETR

    Time frame: 24 timepoints up to 26 day

  6. 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

    Time frame: Up to day 27

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 14, 2014
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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