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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT02063360
First received: February 13, 2014
Last updated: August 7, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention Phase
Infection, Human Immunodeficiency Virus Drug: BMS-663068 Drug: Darunavir (DRV) Drug: Ritonavir (RTV) Drug: Etravirine (ETR) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Open-Label, Single-Sequence Study to Evaluate the Pharmacokinetic Interaction of BMS-663068 With Darunavir/Ritonavir and/or Etravirine in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Maximum observed plasma concentration (Cmax) of BMS-626529 [ Time Frame: 20 timepoints up to day 26 ]
  • Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of BMS-626529 [ Time Frame: 20 timepoints up to day 26 ]

Secondary Outcome Measures:
  • 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) ]
  • 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) ]
  • 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) ]
  • Cmax for DRV, RTV, and ETR [ Time Frame: 24 timepoints up to 26 day ]
  • AUC(TAU) for DRV, RTV, and ETR [ Time Frame: 24 timepoints up to 26 day ]
  • 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 ]

Enrollment: 42
Study Start Date: February 1, 2014
Study Completion Date: May 13, 2014
Primary Completion Date: May 1, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: BMS-663068+DRV/RTV
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-663068
BMS-663068
Drug: Darunavir (DRV)
Darunavir (DRV)
Other Name: Prezista
Drug: Ritonavir (RTV)
Ritonavir (RTV)
Other Name: Norvir
Experimental: Cohort 2: BMS-663068+ETR
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-663068
BMS-663068
Drug: Etravirine (ETR)
Etravirine (ETR)
Other Name: Intelence
Experimental: Cohort 3: BMS-663068+DRV/RTV+ETR
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-663068
BMS-663068
Drug: Darunavir (DRV)
Darunavir (DRV)
Other Name: Prezista
Drug: Ritonavir (RTV)
Ritonavir (RTV)
Other Name: Norvir
Drug: Etravirine (ETR)
Etravirine (ETR)
Other Name: Intelence

Detailed Description:

Brief title: drug-drug interaction (DDI)

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02063360

Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02063360     History of Changes
Other Study ID Numbers: 206281
AI438-020 ( Other Identifier: Bristol-Myers Squibb )
Study First Received: February 13, 2014
Last Updated: August 7, 2017

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Ritonavir
Darunavir
Etravirine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 18, 2017