A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese Subjects

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01472848
First received: March 14, 2011
Last updated: November 11, 2011
Last verified: November 2011
  Purpose

This study examines whether a gradual increase of dose improves the gastrointestinal tolerability (nausea and vomiting) of PF05212389


Condition Intervention Phase
Obesity
Drug: PF 05212389 or placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Outpatient, Placebo-Controlled, Dose Titration Study Of Gastrointestinal Tolerability Of Pf 05212389 (Oap-189) In Obese Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • - Incidence, severity and duration of nausea and vomiting collected as adverse events. [ Time Frame: Day 1 to day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Change in body weight from baseline [ Time Frame: Day 1 to day 28 ] [ Designated as safety issue: No ]
  • - Changes in heart rate, systolic and diastolic blood pressure, and ECG parameters from baseline [ Time Frame: Day 1 to day 28 ] [ Designated as safety issue: Yes ]
  • - Multiple dose PK parameters of PF 05212389 [ Time Frame: Day 1 to day 28 ] [ Designated as safety issue: No ]
  • - 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2011
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 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.
Experimental: Cohort 2 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.
Experimental: Cohort 3 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 4 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 5 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
Active Comparator: Cohort 6 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472848

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01472848     History of Changes
Other Study ID Numbers: B2201010
Study First Received: March 14, 2011
Last Updated: November 11, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014