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.

• ClinicalTrials.gov Identifier: NCT00857571
• Recruitment Status: Terminated
• First Posted: March 6, 2009
• Last Update Posted: December 7, 2018
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: March 5, 2009
• First Posted Date: March 6, 2009
• Last Update Posted Date: December 7, 2018
• Study Start Date: April 2009
• Actual Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 5, 2009): Pharmacokinetics: Cmax, AUCinf [ Time Frame: June - July 2009 ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00857571 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: March 5, 2009): Tmax, Tlag, AUClast, AUCt, t½, Frel. [ Time Frame: June-July 2009 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• 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.
• Brief Summary: The study compares the plasma concentrations of PF-02413873 after administration of several doses as suspension and as tablets
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

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

Study Arms

• Experimental: Suspension
  PF-02413873 suspension
  Interventions:

  • Drug: 150 mg Suspension
  • Drug: 30 mg Suspension
  • Drug: 400 mg Suspension
  • Drug: 5 mg Suspension
  • Drug: 750 mg Suspension
• Experimental: Tablet
  PF-02413873 Phase 2 Tablets
  Interventions:

  • Drug: 150 mg Tablet
  • Drug: 30 mg Tablet
  • Drug: 400 mg Tablet
  • Drug: 5 mg Tablet
  • Drug: 750 mg Tablet

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 5, 2018): 12
• Original Estimated Enrollment (submitted: March 5, 2009): 30
• Actual Study Completion Date: May 2009
• Actual Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT00857571
• Other Study ID Numbers: B0461003
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: December 2018