NCT01841489 - 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

August 31, 2013

Study Completion Date

October 31, 2013

Conditions

Chronic Lymphocytic Leukemia

Interventions

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

Trial Locations (1)

Investigational Site, Daytona Beach