This is a Phase 1, Open-Label, Adaptive Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
1600 mg GS-9973 (Formulation 1)
1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole
1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine
Investigational Site
Daytona Beach, Florida, United States
Pharmacokinetic parameters for GS-9973
The primary outcome measure is the pharmacokinetic (PK) parameters for GS-9973 including AUC and Cmax.
Time frame: Up to 3 months
Secondary pharmacokinetic parameters for GS-9973
A secondary outcome measure is the pharmacokinetic parameters for GS-9973 including Ctau and AUClast.
Time frame: Up to 3 months
Incidence of Adverse Events
A secondary outcome measure is the safety and tolerability of GS-9973 which will be evaluated by the incidence of AEs including assessment of clinical laboratory test findings, physical examinations, 12-lead ECG abnormalities, and vital signs measurements.
Time frame: Up to 3 months
Blood PD parameters for GS-9973
A secondary outcome measure is the blood pharmacodynamic parameters.
Time frame: Up to 3 months
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1600 mg GS-9973 (Formulation 2)
1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole
1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine
1600 mg GS-9973 (Reference formulation)
1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A)
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily