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
Verified date | August 2017 |
Source | ViiV Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
ViiV Healthcare | GlaxoSmithKline |
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 |
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