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Trial record 1 of 1 for:    NCT01776619
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Safety and Tolerability Study of Multiple Doses of PF-06305591

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ClinicalTrials.gov Identifier: NCT01776619
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : December 3, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 23, 2013
First Posted Date  ICMJE January 28, 2013
Last Update Posted Date December 3, 2013
Study Start Date  ICMJE April 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2013)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 14 days ]
    Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 14 days ]
  • Area under the Concentration-Time Curve (AUC) [ Time Frame: 14 days ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: 14 days ]
    AUC is a measure of the serum concentration of the drug over time interval. It is used to characterize drug absorption.
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2013)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 14 days ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 14 days ]
  • Area under the Concentration-Time Curve (AUC) [ Time Frame: 14 days ]
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: 14 days ]
Change History Complete list of historical versions of study NCT01776619 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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