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A Phase 1, Open-Label, Crossover Study to Evaluate the Drug Interaction Between Dolutegravir and Daclatasvir in Healthy Adult Subjects
This study is designed to estimate the two-way drug interaction between DCV and DTG as a drug interaction between DTG and DCV is expected to be low and this study is to be performed as confirmation. This will be a single-center, open-label, three-period, crossover study in healthy adult subjects. This study to describe and compare steady-state plasma DTG and DCV pharmacokinetics following administration of DTG 50 mg q24h with and without DCV 60 mg q24h and following administration of DCV 60 mg q24h with and without DTG 50 mg q24h also the safety and tolerability was assessed after a repeat dose DTG 50 mg q24h with or without DCV 60 mg q24h and after a repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h
Details
| Lead sponsor | ViiV Healthcare |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 12 |
| Start date | 2014-03 |
| Completion | 2014-05 |
Conditions
- Infection, Human Immunodeficiency Virus
Interventions
- DTG
- DCV
Primary outcomes
- Composite of PK parameters of DTG following DTG 50 mg q24h administration with and without DCV 60mg q24h — Day 5 in Period 1 or 2, and Period 3: pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 8, 12 and 24 hours post morning dose
Plasma PK parameters for DTG include steady state area under the concentration-time curve over the dosing interval (AUC (0-tau)), maximum observed concentration (Cmax), concentration at the end of the dosing interval (Ctau), apparent clearance following oral dosing (CL/F) and terminal phase half-life (t1/2) , following DTG 50 mg q24h administration with and without DCV 60mg q24h - Composite of PK parameters of DCV following administration of DCV 60 mg q24h with and without DTG 50 mg q24h — Day 5 (Periods 1 or 2, and Period 3): pre-dose (within 15 minutes prior to dosing), 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24hrs post morning dose
Plasma DCV steady state AUC(0-tau), Cmax, Ctau, CL/F and t1/2 following administration of DCV 60 mg q24h with and without DTG 50 mg q24h
Countries
United States