A Four-Way Cross-Over Study To Compare The Plasma Concentrations Of PF-02413873 After Oral Administration Of Several Doses As Suspension And As Tablets.

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: 150 mg Suspension; Drug: 150 mg Tablet; Drug: 30 mg Suspension; Drug: 30 mg Tablet; Drug: 400 mg Suspension; Drug: 400 mg Tablet; Drug: 5 mg Suspension; Drug: 5 mg Tablet; Drug: 750 mg Suspension; Drug: 750 mg Tablet

• Registration Number: NCT00857571
• Lead Sponsor: Pfizer

Brief Summary

The study compares the plasma concentrations of PF-02413873 after administration of several doses as suspension and as tablets

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Study Start: 2009-04
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-05
• Last Update Posted: 2018-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Healthy male and female volunteers.
• Female volunteers have to be of non-childbearing potential

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• A positive urine drug screen.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Suspension	150 mg Suspension	PF-02413873 suspension
Suspension	30 mg Suspension	PF-02413873 suspension
Suspension	400 mg Suspension	PF-02413873 suspension
Suspension	5 mg Suspension	PF-02413873 suspension
Suspension	750 mg Suspension	PF-02413873 suspension
Tablet	150 mg Tablet	PF-02413873 Phase 2 Tablets
Tablet	30 mg Tablet	PF-02413873 Phase 2 Tablets
Tablet	400 mg Tablet	PF-02413873 Phase 2 Tablets
Tablet	5 mg Tablet	PF-02413873 Phase 2 Tablets
Tablet	750 mg Tablet	PF-02413873 Phase 2 Tablets

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Cmax, AUCinf	June - July 2009

Secondary Outcome Measures

Name	Time	Method
Tmax, Tlag, AUClast, AUCt, t½, Frel.	June-July 2009

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore