Study Evaluating the Safety and Pharmacokinetics of a Single Dose of GSI-953

Phase 1CompletedNCT00441987

Wyeth is now a wholly owned subsidiary of Pfizer96 enrolled

Overview

The purpose of the protocol is to assess the initial pharmacokinetic (PK) profile of a single oral dose of GSI-953 to healthy male Japanese subjects and healthy elderly male Japanese subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

GSI-953DRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 120 YearsHealthy volunteers:

Medical Language ↔ Plain English

* Healthy males aged 20 - 40 and healthy males aged greater than 65. * Body mass index range of 17.6 - 26.4 kg/m2 greater than or equal to 45 kg. * Non-smokers or smoker of fewer than 10 cigarettes a day.

Locations (1)

Unnamed facility

Kitashinagawa, Shinagawa-ku, Japan

Outcomes

Primary Outcomes

Number of participants reporting Adverse Event

Safety

Time frame: 10 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.