Multiple Dose Safety Study of PF-04802540 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-04802540; Drug: Placebo

• Registration Number: NCT00756743
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to healthy adult subjects.

Detailed Description

Evaluation of safety and pharmacokinetics

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-19
• Study First Submitted QC: 2008-09-19
• Study First Posted: 2008-09-22
• Status Verified: 2009-01
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Last Update Submitted: 2010-03-17
• Last Update Posted: 2010-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Males or females of non-childbearing capacity aged 21 to 55 years inclusive at screening.
• Body mass index in the range of 18 to 30 kg/m2 and body weight>45 kg.
• Healthy as determined by the investigator on the basis of screening evaluation.

Exclusion Criteria

• Use of prescription or nonprescription drugs
• Any condition possibly affecting drug absorption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-04802540	PF-04802540	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Adverse events	12 days
Safety assessments: vital signs, ECG, physical examination, laboratory tests	12 days
Pharmacokinetics	12 days

Secondary Outcome Measures

Name	Time	Method
No secondary outcomes measures.	Timeframe N/A

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore