A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese Subjects

Obesity Clinical Trial

Official title:

A Randomized, Double-Blind, Outpatient, Placebo-Controlled, Dose Titration Study Of Gastrointestinal Tolerability Of Pf 05212389 (Oap-189) In Obese Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01472848
• Other study ID #: B2201010
• Status: Withdrawn
• Phase: Phase 1
• First received: March 14, 2011
• Last updated: November 11, 2011
• Start date: April 2011
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• PF 05212389 or placebo
QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose.
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Incidence, severity and duration of nausea and vomiting collected as adverse events.		Day 1 to day 28	No
Secondary	- Change in body weight from baseline		Day 1 to day 28	No
Secondary	- Changes in heart rate, systolic and diastolic blood pressure, and ECG parameters from baseline		Day 1 to day 28	Yes
Secondary	- Multiple dose PK parameters of PF 05212389		Day 1 to day 28	No
Secondary	- Treatment modification defined as a decrease in any dose of, or discontinuation from, study medication for any reason		Day 1 to day 28	No

External Links

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