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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014