A Study to Evaluate the Effect of Boceprevir and Telaprevir on Dolutegravir Pharmacokinetics in Healthy Adult Subjects (ING115697).
|ClinicalTrials.gov Identifier: NCT01563328|
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : March 28, 2017
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3 clinical development for the treatment of human immunodeficiency virus (HIV) infection. Co-infection with Hepatitis C (HCV) is common in HIV-infected subjects therefore it is expected that DTG will be coadministered with treatments for HCV. Boceprevir (BCV) and Telaprevir (TVR) are protease inhibitors for the treatment of HCV that were recently approved by the Food and Drug Administration/European Medicines Agency (FDA/EMA) and have rapidly been adopted to "standard of care" in combination with pegylated interferon and ribavarin. This is a single-center, open-label, two-cohort, two-period, one-way, study in healthy adult subjects. A total of approximately 32 subjects will be enrolled, in order to obtain 24 evaluable subjects (12 per cohort). In the first treatment period, all subjects will receive DTG 50 mg once daily for 5 days (treatment A). In period 2, subjects will receive DTG 50 mg once daily plus either BCV 800 mg q8h (treatment B) for 10 days or TVR 750 mg q8h (treatment C) for 10 days. There will be no washout between treatments. Safety evaluations and serial PK samples will be collected during each treatment period.
Subjects will have a screening visit within 30 days prior to the first dose of study drug, two treatment periods, and a follow-up visit 7-14 days after the last dose of study drug.
This study will be conducted at one center in the US, with healthy adult male and female subjects.
|Condition or disease||Intervention/treatment||Phase|
|Infection, Human Immunodeficiency Virus||Drug: DTG Drug: BCV Drug: TVR||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open Label, Randomized, Two Cohort, Two Period, Oneway Study to Evaluate the Effect of Boceprevir and Telaprevir onDolutegravir Pharmacokinetics in Healthy Adult Subjects (ING115697)|
|Study Start Date :||March 1, 2012|
|Actual Primary Completion Date :||May 1, 2012|
|Actual Study Completion Date :||May 1, 2012|
Experimental: Cohort 1
DTG x 5 days followed by BCV + DTG x 10 days
50 mg q24h
Other Name: DolutegravirDrug: BCV
800 mg q8h
Other Name: Boceprevir
Experimental: Cohort 2
DTG x 5 days followed by TVR + DTG x 10 days
50 mg q24h
Other Name: DolutegravirDrug: TVR
750 mg q8h
Other Name: Telaprevir
- Plasma steady-state DTG PK parameters AUC(0-τ), Cmax, Cmin, and Cτ [ Time Frame: For 24 hours after dosing on Period 1 Day 5 and Period 2 Day 10 ]Samples will be collected at predose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose
- Safety and tolerability parameters as assessed by change from baseline in vital signs n(BP and HR), number of subjects with adverse events and toxicity grading of clinical laboratory tests. [ Time Frame: Up to 29 days ]
- Plasma steady-state DTG tmax and t1/2 [ Time Frame: For 24 hours after dosing on Period 1 Day 5 and Period 2 Day 10 ]Samples will be collected at predose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose
- Plasma steady-state TVR and BCV AUC(0-t), Cmax, Cmin, and Ct [ Time Frame: For 8 hours after dosing on Period 2, Day 10 ]Samples will be collected at predose and at 1, 2, 3, 4, and 8 hours post dose
- Plasma steady-state TVR and BCV tmax and t1/2 [ Time Frame: For 8 hours after dosing on Period 2, Day 10 ]Samples will be collected at predose and at 1, 2, 3, 4, and 8 hours post dose
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563328
|United States, Texas|
|GSK Investigational Site|
|Austin, Texas, United States, 78744|
|Study Director:||GSK Clinical Trials||ViiV Healthcare|