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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This study has been withdrawn prior to enrollment.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
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • - 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472848


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01472848     History of Changes
Other Study ID Numbers: B2201010
First Submitted: March 14, 2011
First Posted: November 17, 2011
Last Update Posted: November 17, 2011
Last Verified: November 2011