Safety and Tolerability Study of Multiple Doses of PF-06305591

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NCT01776619

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Study Location
Pfizer Investigational Site
Brussels, , B-1070, Belgium
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male or female subjects of non childbearing potential, between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).


- Any condition possibly affecting drug absorption (eg, gastrectomy).

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Tolerability Study of Multiple Doses of PF-06305591
Official Title  ICMJE A Double Blind (3rd Party Open) Randomized, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics of Repeat Doses PF-06305591 Combined With a Cross-over Relative Bioavailability and Food Effect Evaluation After Single Dose of PF-06305591 in Healthy Young Subjects
Brief Summary Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young healthy volunteers toghether with food effect on relative bioavailability of solid formulation after single dose.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-06305591
    14 day repeated 20mg BID doses
  • Drug: Placebo
    14 day repeated BID doses
  • Drug: PF-06305591
    14 day repeated 80mg BID doses
  • Drug: PF-06305591
    14 day repeated 40mg BID doses
  • Drug: PF-06305591
    14 day repeated BID doses
  • Drug: PF-06305591
    relative bioavailability tablet vs. solution and food effect at 50mg dose
Study Arms  ICMJE
  • Experimental: Multiple Dose: Cohort 1
    Interventions:
    • Drug: PF-06305591
    • Drug: Placebo
  • Experimental: Multiple Dose: Cohort 2
    Interventions:
    • Drug: PF-06305591
    • Drug: Placebo
  • Experimental: Multiple Dose: Cohort 3
    Interventions:
    • Drug: PF-06305591
    • Drug: Placebo
  • Experimental: Multiple Dose: Cohort 4
    Intervention: Drug: PF-06305591
  • Experimental: Relative Bioavilability: Cohort 1
    Intervention: Drug: PF-06305591
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 2, 2013)		43
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2013)		30
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male or female subjects of non childbearing potential, between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests

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).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 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 NCT01776619
Other Study ID Numbers  ICMJE B5281002
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 CenterPfizer
PRS Account Pfizer
Verification Date December 2013

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