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A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese Subjects

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01472848
First Posted: November 17, 2011
Last Update Posted: November 17, 2011
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.
Information provided by:
Pfizer
March 14, 2011
November 17, 2011
November 17, 2011
April 2011
July 2011   (Final data collection date for primary outcome measure)
- Incidence, severity and duration of nausea and vomiting collected as adverse events. [ Time Frame: Day 1 to day 28 ]
Same as current
No Changes Posted
  • - Change in body weight from baseline [ Time Frame: Day 1 to day 28 ]
  • - Changes in heart rate, systolic and diastolic blood pressure, and ECG parameters from baseline [ Time Frame: Day 1 to day 28 ]
  • - Multiple dose PK parameters of PF 05212389 [ Time Frame: Day 1 to day 28 ]
  • - Treatment modification defined as a decrease in any dose of, or discontinuation from, study medication for any reason [ Time Frame: Day 1 to day 28 ]
Same as current
Not Provided
Not Provided
 
A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese Subjects
A Randomized, Double-Blind, Outpatient, Placebo-Controlled, Dose Titration Study Of Gastrointestinal Tolerability Of Pf 05212389 (Oap-189) In Obese Subjects
This study examines whether a gradual increase of dose improves the gastrointestinal tolerability (nausea and vomiting) of PF05212389
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Obesity
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2011
July 2011   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01472848
B2201010
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2011

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