A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese Subjects

November 11, 2011 updated by: Pfizer

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 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.
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 3
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 4
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 5
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
Active Comparator: Cohort 6
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
- Incidence, severity and duration of nausea and vomiting collected as adverse events.
Time Frame: Day 1 to day 28
Day 1 to day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
- Change in body weight from baseline
Time Frame: Day 1 to day 28
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
Day 1 to day 28
- Multiple dose PK parameters of PF 05212389
Time Frame: Day 1 to day 28
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
Day 1 to day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

March 14, 2011

First Submitted That Met QC Criteria

November 11, 2011

First Posted (Estimate)

November 17, 2011

Study Record Updates

Last Update Posted (Estimate)

November 17, 2011

Last Update Submitted That Met QC Criteria

November 11, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • B2201010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on PF 05212389 or placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe