A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese Subjects

Phase 1

Withdrawn

• Conditions: Obesity
• Interventions: Drug: PF 05212389 or placebo

• Registration Number: NCT01472848
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-14
• Study Start: 2011-04
• Primary Completion: 2011-07
• Study Completion: 2011-08
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-11
• Last Update Submitted: 2011-11-11
• Study First Posted: 2011-11-17
• Last Update Posted: 2011-11-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	PF 05212389 or placebo	-
Cohort 1	PF 05212389 or placebo	-
Cohort 3	PF 05212389 or placebo	-
Cohort 4	PF 05212389 or placebo	-
Cohort 5	PF 05212389 or placebo	-
Cohort 6	PF 05212389 or placebo	-

Primary Outcome Measures

Name	Time	Method
- Incidence, severity and duration of nausea and vomiting collected as adverse events.	Day 1 to day 28

Secondary Outcome Measures

Name	Time	Method
- Change in body weight from baseline	Day 1 to day 28
- Changes in heart rate, systolic and diastolic blood pressure, and ECG parameters from baseline	Day 1 to day 28
- Multiple dose PK parameters of PF 05212389	Day 1 to day 28
- Treatment modification defined as a decrease in any dose of, or discontinuation from, study medication for any reason	Day 1 to day 28