Trials / Completed
CompletedNCT01841489
A Phase 1 Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Treatment A | 1600 mg GS-9973 (Formulation 1) |
| DRUG | Treatment B | 1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole |
| DRUG | Treatment C | 1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine |
| DRUG | Treatment D | 1600 mg GS-9973 (Formulation 2) |
| DRUG | Treatment E | 1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole |
| DRUG | Treatment F | 1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine |
| DRUG | Treatment G | 1600 mg GS-9973 (Reference formulation) |
| DRUG | Treatment H | 1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A) |
| DRUG | Treatment I | An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily |
| DRUG | Treatment J | An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2013-08-01
- Completion
- 2013-10-01
- First posted
- 2013-04-26
- Last updated
- 2014-02-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01841489. Inclusion in this directory is not an endorsement.