Study Evaluating the Gastrointestinal Safety of PLA-695 Compared to Placebo and Naproxen

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Naproxen; Drug: Placebo; Drug: PLA-695

Study type: Interventional

Funder types: Industry

Identifiers

NCT00366262

3175A1-103

Details and patient eligibility

About

The purpose of this study is to provide an initial assessment of the gastrointestinal safety of a 7-day regimen of PLA-695 compared to placebo or naproxen.

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men or women of nonchildbearing potential, aged 18 to 60 years.

Exclusion criteria

• Abnormal baseline endoscopy.
• Positive Helicobacter pylori serology.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind