Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
An Open Label, Single Dose, Mass Balance Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK2248761 200 mg, Administered as an Oral Suspension to Healthy Adult Subjects
This study is a Phase I, open-label, single dose, mass balance study in a cohort of 6 healthy adult male subjects. The study will consist of: Screening evaluations, a treatment phase, and follow-up evaluations. In the treatment phase, after an overnight fast of at least 10 hours, each subject will receive a single oral suspension dose of GSK2248761 200mg containing [14C] - GSK2248761. Following dosing, serial whole blood, plasma, urine, and fecal samples will be collected. Subjects will be required to remain in the unit until the radiocarbon excreted falls to less than or equal to 1% of the administered dose for two consecutive 24-hour collections in both urine and feces, whichever occurs first. Safety will be assessed by vital signs, 12-lead electrocardiogram (ECG), clinical laboratory tests, AE monitoring, and physical examinations as indicated.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship ;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01425099 -
Drug Interaction Study Between Dolutegravir and Prednisone
|
Phase 1 | |
| Completed |
NCT01209117 -
A Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435
|
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 |
NCT01077557 -
Fractures Stratified by HIV and Antiretroviral Therapy (ART) Status
|
N/A |