Investigational Site
Daytona Beach, Florida, 32117, United States
NCT Number: NCT01841489
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.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Daytona Beach, Florida, 32117, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: Up to 3 months
The primary outcome measure is the pharmacokinetic (PK) parameters for GS-9973 including AUC and Cmax.
Time frame: Up to 3 months
A secondary outcome measure is the pharmacokinetic parameters for GS-9973 including Ctau and AUClast.
Time frame: Up to 3 months
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
A secondary outcome measure is the blood pharmacodynamic parameters.
Gilead Sciences
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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