Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01747941
Previous Study | Return to List | Next Study

Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01747941
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : May 23, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 5, 2012
First Posted Date  ICMJE December 12, 2012
Last Update Posted Date May 23, 2013
Study Start Date  ICMJE November 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2013)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 72 hr ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 72h ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2013)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 72 hr ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 72h ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects
Official Title  ICMJE A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Crossover Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects
Brief Summary The study is designed to test safety tolerability and PK of single oral ascending doses of PF-06305591,
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-06305591
    single dose, solution
  • Drug: Placebo
    matching placebo
Study Arms  ICMJE
  • Experimental: Cohort 1
    Single ascending oral doses in fasted conditions
    Interventions:
    • Drug: PF-06305591
    • Drug: Placebo
  • Experimental: Cohort 2
    Single ascending oral doses in fasted conditions
    Interventions:
    • Drug: PF-06305591
    • Drug: Placebo
  • Experimental: Cohort 3
    Single ascending oral doses in fed conditions
    Interventions:
    • Drug: PF-06305591
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy young subjects
  • aged 18-55

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 the time of dosing).
  • Pregnant or nursing females; females of childbearing potential.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01747941
Other Study ID Numbers  ICMJE B5281001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP