Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
A Single-center, Randomized, Open-label, Crossover Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435
This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects to assess the oral bioavailability of three GSK2248761 Wet Bead Milled (WBM) tablet formulations manufactured by three different processes relative to the GSK2248761 WBM capsule formulation (Part A) and the effect of a moderate-fat meal on the bioavailability of the selected WBM tablet formulation (Part B).
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01425099 -
Drug Interaction Study Between Dolutegravir and Prednisone
|
Phase 1 | |
| Completed |
NCT03231943 -
GSK3640254 First Time in Human (FTIH) Study in Healthy Volunteers
|
Phase 1 | |
| Terminated |
NCT01195974 -
A Study to Evaluate the Pharmacokinetics of an Oral Contraceptive When Co-administered With GSK2248761 in Healthy Adult Female Subjects.
|
Phase 1 | |
| Completed |
NCT02893488 -
Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet
|
Phase 1 | |
| Terminated |
NCT01199731 -
Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection
|
Phase 2 | |
| Completed |
NCT01449929 -
Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects
|
Phase 3 | |
| Active, not recruiting |
NCT02951052 -
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults
|
Phase 3 | |
| Completed |
NCT01231516 -
A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults
|
Phase 3 | |
| Completed |
NCT02273947 -
Food Effect Study With BMS-955176
|
Phase 1 | |
| Completed |
NCT00071760 -
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
|
Phase 2 | |
| Completed |
NCT02539576 -
Pharmacokinetics, Safety and Tolerability Study of Abacavir/ Dolutegravir/ Lamivudine Fixed-dose Combination Tablets in Healthy Japanese Subjects
|
Phase 1 | |
| Completed |
NCT01967771 -
Effect of Carbamazepine on Dolutegravir Pharmacokinetics in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT01077635 -
PENTA Fosamprenavir Study
|
N/A | |
| Completed |
NCT00774735 -
GSK1349572 Drug Interaction Study With Protease Inhibitors
|
Phase 1 | |
| Completed |
NCT00386347 -
A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.
|
Phase 1 | |
| Completed |
NCT00945282 -
Safety and Tolerability Study to Evaluate Lower Dose of GSK2248761 in Antiretroviral Treatment-Naive HIV-1 Infected Adults.
|
Phase 2 | |
| Terminated |
NCT02576119 -
A Study to Determine the Effect of Multiple Doses of BMS-955176 on the Electrocardiograph of Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02277600 -
A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)
|
Phase 1 | |
| Completed |
NCT00398125 -
Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults
|
Phase 2 | |
| Completed |
NCT01077557 -
Fractures Stratified by HIV and Antiretroviral Therapy (ART) Status
|
N/A |