DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)
Primary Purpose
Infection, Human Immunodeficiency Virus
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BMS-663068
Darunavir (DRV)
Ritonavir (RTV)
Etravirine (ETR)
Sponsored by
About this trial
This is an interventional other trial for Infection, Human Immunodeficiency Virus
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1: BMS-663068+DRV/RTV
Cohort 2: BMS-663068+ETR
Cohort 3: BMS-663068+DRV/RTV+ETR
Arm Description
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
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
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
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax) of BMS-626529
Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of BMS-626529
Secondary Outcome Measures
Time of maximum observed plasma concentration (Tmax) for BMS-626529, DRV, RTV, and ETR
Concentration at 12 hours (C12) for BMS-626529, DRV, RTV, and ETR
Trough observed plasma concentration (Ctrough) for BMS-626529, DRV, RTV, and ETR
Cmax for DRV, RTV, and ETR
AUC(TAU) 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
Full Information
NCT ID
NCT02063360
First Posted
February 13, 2014
Last Updated
August 7, 2017
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT02063360
Brief Title
DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)
Official Title
Open-Label, Single-Sequence Study to Evaluate the Pharmacokinetic Interaction of BMS-663068 With Darunavir/Ritonavir and/or Etravirine in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2014 (undefined)
Primary Completion Date
May 1, 2014 (Actual)
Study Completion Date
May 13, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: BMS-663068+DRV/RTV
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 2: BMS-663068+ETR
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 3: BMS-663068+DRV/RTV+ETR
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
BMS-663068
Intervention Description
BMS-663068
Intervention Type
Drug
Intervention Name(s)
Darunavir (DRV)
Other Intervention Name(s)
Prezista
Intervention Description
Darunavir (DRV)
Intervention Type
Drug
Intervention Name(s)
Ritonavir (RTV)
Other Intervention Name(s)
Norvir
Intervention Description
Ritonavir (RTV)
Intervention Type
Drug
Intervention Name(s)
Etravirine (ETR)
Other Intervention Name(s)
Intelence
Intervention Description
Etravirine (ETR)
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) of BMS-626529
Time Frame
20 timepoints up to day 26
Title
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 Measure Information:
Title
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)
Title
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)
Title
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)
Title
Cmax for DRV, RTV, and ETR
Time Frame
24 timepoints up to 26 day
Title
AUC(TAU) for DRV, RTV, and ETR
Time Frame
24 timepoints up to 26 day
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
35315687
Citation
Moore K, Thakkar N, Magee M, Sevinsky H, Vakkalagadda B, Lubin S, Llamoso C, Ackerman P. Pharmacokinetics of Temsavir, the Active Moiety of the HIV-1 Attachment Inhibitor Prodrug, Fostemsavir, Coadministered with Cobicistat, Etravirine, Darunavir/Cobicistat, or Darunavir/Ritonavir with or without Etravirine in Healthy Participants. Antimicrob Agents Chemother. 2022 Apr 19;66(4):e0225121. doi: 10.1128/aac.02251-21. Epub 2022 Mar 22.
Results Reference
derived
Learn more about this trial
DDI Study of BMS-663068 With Etravirine (ETR) and/or Darunavir (DVR) + Ritonavir (RTV)
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