Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02893488

Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet

Infection, Human Immunodeficiency Virus Clinical Trial

Official title:
A Phase I, Single Dose, Five-period Crossover Relative Bioavailability Study of a Fixed-dose Combination Dolutegravir/Abacavir/Lamivudine Dispersible Tablet as Compared to a Co-dose of TIVICAY and EPZICOM in Healthy Subjects

Clinical Trial Summary

This is an open-label, randomized, crossover study in healthy adult subjects with 5 treatment groups over 5 dosing periods. This study will evaluate pharmacokinetic parameters and relative bioavailability of a dispersible, fixed-dose combination (FDC) tablet of TRIUMEQ™ ([abacavir, ABC]/[dolutegravir, DTG]/[lamivudine, 3TC]) when dispersed and consumed under four different dosing conditions in comparison to an oral dose of TIVICAY™ (DTG) + EPZICOM™ (ABC/3TC) non-dispersible tablets administered in the fasted state. Approximately 20 subjects will be randomized, each to one of 5 treatment groups. The total duration of participation of a subject in this study will be approximately 10-11 weeks. It will include a screening visit within 30 days prior to the first dose of study drug, five treatment periods each with a single dose of study drug per treatment period and a follow up visit within 7 10 days after the last dose. There will also be a washout of at least 7 days between doses in each treatment period. TRIUMEQ, EPZICOM, and TIVICAY are trademarks of the GlaxoSmithKline group of companies.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02893488
Study type Interventional
Source ViiV Healthcare
Contact
Status Completed
Phase Phase 1
Start date September 1, 2016
Completion date November 25, 2016
View Details
See also
  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
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
Completed NCT00398125 - Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults Phase 2