A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03893787 In Healthy Adult Volunteers

• ClinicalTrials.gov Identifier: NCT00992342
• Recruitment Status: Completed
• First Posted: October 9, 2009
• Last Update Posted: March 18, 2010
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: October 8, 2009
• First Posted Date: October 9, 2009
• Last Update Posted Date: March 18, 2010
• Study Start Date: November 2009
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 8, 2009): Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood (including creatine kinase) and urine safety tests and physical examination. [ Time Frame: 22 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 8, 2009): Pharmacokinetic parameters: Cmax, Tmax, AUCτ, t½, accumulation ratio, [ Time Frame: 22 days ]
• 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 Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03893787 In Healthy Adult Volunteers
• Official Title: A Double Blind (3rd Party Open), Randomised, Placebo-Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Oral Doses Of PF-03893787 In Healthy Subjects
• Brief Summary: The purpose of this study is to investigate safety and toleration of multiple oral doses as well as the time course of PF-03893787 concentration in the blood following dosing by oral solution.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• Drug: PF-03893787
  oral solution, 5 mg, QD for 14 days
• Drug: PF-03893787
  oral solution, 15 mg, QD for 14 days
• Drug: PF-03893787
  oral solution, 50 mg, QD for 14 days

Study Arms

• Experimental: PF-03893787 5 mg
  Intervention: Drug: PF-03893787
• Experimental: PF-03893787 15 mg
  Intervention: Drug: PF-03893787
• Experimental: PF-03893787 50 mg
  Intervention: Drug: PF-03893787

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 8, 2009): 36
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2010
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy male subjects and females of non-childbearing potential between the ages of 18 and 55 years.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs).

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).
• A positive urine drug screen.
• History of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT00992342
• Other Study ID Numbers: B0281003
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

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

• PRS Account: Pfizer
• Verification Date: March 2010