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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02063360
First received: February 13, 2014
Last updated: August 13, 2014
Last verified: August 2014
  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
HIV/AIDS
Drug: BMS-663068
Drug: Darunavir (DRV)
Drug: Ritonavir (RTV)
Drug: Etravirine (ETR)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 Bristol-Myers Squibb:

Primary Outcome Measures:
  • Maximum observed plasma concentration (Cmax) of BMS-626529 [ Time Frame: 20 timepoints up to day 26 ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of BMS-626529 [ Time Frame: 20 timepoints up to day 26 ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Cmax for DRV, RTV, and ETR [ Time Frame: 24 timepoints up to 26 day ] [ Designated as safety issue: No ]
  • AUC(TAU) for DRV, RTV, and ETR [ Time Frame: 24 timepoints up to 26 day ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: February 2014
Study Completion Date: May 2014
Primary Completion Date: May 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 Drug: Darunavir (DRV)
Other Name: Prezista
Drug: 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 Drug: 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 Drug: Darunavir (DRV)
Other Name: Prezista
Drug: Ritonavir (RTV)
Other Name: Norvir
Drug: 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02063360     History of Changes
Other Study ID Numbers: AI438-020
Study First Received: February 13, 2014
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ritonavir
Darunavir
Etravirine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014