A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese Subjects

NCT01472848

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obesity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Obesity

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


Diabetes mellitus (type 1 or type 2) Heart failure Eating disorders Psychiatric disorders
History of suicide attempt History of pancreatitis

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese Subjects
Official Title  ICMJE A Randomized, Double-Blind, Outpatient, Placebo-Controlled, Dose Titration Study Of Gastrointestinal Tolerability Of Pf 05212389 (Oap-189) In Obese Subjects
Brief Summary This study examines whether a gradual increase of dose improves the gastrointestinal tolerability (nausea and vomiting) of PF05212389
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: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: PF 05212389 or placebo
    QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose.
  • Drug: PF 05212389 or placebo
    QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts
Study Arms  ICMJE
  • Experimental: Cohort 1
    Intervention: Drug: PF 05212389 or placebo
  • Experimental: Cohort 2
    Intervention: Drug: PF 05212389 or placebo
  • Experimental: Cohort 3
    Intervention: Drug: PF 05212389 or placebo
  • Experimental: Cohort 4
    Intervention: Drug: PF 05212389 or placebo
  • Experimental: Cohort 5
    Intervention: Drug: PF 05212389 or placebo
  • Active Comparator: Cohort 6
    Intervention: Drug: PF 05212389 or 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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 11, 2011)
0
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2011
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Obesity

Exclusion Criteria:

Diabetes mellitus (type 1 or type 2) Heart failure Eating disorders Psychiatric disorders History of suicide attempt History of pancreatitis

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01472848
Other Study ID Numbers  ICMJE B2201010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2011

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