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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
DTG is provided as 9 millimetre white, film-coated, round tablets debossed with SV 572 on one side and 50 on the other side
DCV is provided as a plain, green, biconvex, pentagonal film-coated tablet
GSK Investigational Site
Overland Park, Kansas, United States
Composite of PK parameters of DTG following DTG 50 mg q24h administration with and without DCV 60mg q24h
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
Time frame: 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
Composite of PK parameters of DCV following administration of DCV 60 mg q24h with and without DTG 50 mg q24h
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
Time frame: 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
Safety and Tolerability of DTG and DCV as assessed by adverse event
Safety and tolerability of repeat dose DTG 50 mg q24h with or without DCV 60 mg q24h and repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h will be assessed by adverse events
Time frame: Up to 36 days
Safety and Tolerability of DTG and DCV as assessed by concurrent medication
Safety and tolerability of repeat dose DTG 50 mg q24h with or without DCV 60 mg q24h and repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h will be assessed by concurrent medication
Time frame: Up to 36 days
Safety and Tolerability of DTG and DCV as assessed by clinical laboratory
Safety and tolerability of repeat dose DTG 50 mg q24h with or without DCV 60 mg q24h and repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h will be assessed by clinical laboratory
Time frame: Up to 36 days
Safety and Tolerability of DTG and DCV as assessed by ECG
Safety and tolerability of repeat dose DTG 50 mg q24h with or without DCV 60 mg q24h and repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h will be assessed by ECG
Time frame: Screening
Safety and Tolerability of DTG and DCV as assessed by vital signs assessments
Safety and tolerability of repeat dose DTG 50 mg q24h with or without DCV 60 mg q24h and repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h will be assessed by vital signs assessments (blood pressure and heart rate)
Time frame: Up to 36 days
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