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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

NCT01841489 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2014-02-07

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Michael Hawkins, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-08-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01841489 on ClinicalTrials.gov