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NCT00857571 Clinical Trial

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.

Healthy Clinical Trial

Official title:
An Open-Label Randomized Incomplete Block Four-Way Crossover Study To Evaluate The Dose Response Of PF-02413873 Tablets And PF-02413873 Suspension.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00857571
Other study ID # B0461003
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date April 2009
Est. completion date May 2009

Study information
Verified date December 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• 150 mg Suspension
Single oral dose of 150 mg of PF-02413873 suspension
• 30 mg Suspension
Single oral dose of 30 mg of PF-02413873 suspension
• 400 mg Suspension
Single oral dose of 400 mg of PF-02413873 suspension
• 5 mg Suspension
Single oral dose of 5 mg of PF-02413873 suspension
• 750 mg Suspension
Single oral dose of 750 mg of PF-02413873 suspension
• 150 mg Tablet
Single oral dose of 150 mg of PF-02413873 tablets
• 30 mg Tablet
Single oral dose of 30 mg of PF-02413873 tablets
• 400 mg Tablet
Single oral dose of 400 mg of PF-02413873 tablets
• 5 mg Tablet
Single oral dose of 5 mg of PF-02413873 tablets
• 750 mg Tablet
Single oral dose of 750 mg of PF-02413873 tablets

Locations
Country Name City State
Singapore Pfizer Investigational Site Singapore

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics: Cmax, AUCinf June - July 2009
Secondary Tmax, Tlag, AUClast, AUCt, t½, Frel. June-July 2009
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