A Study Of Gastrointestinal Tolerability Of PF05212389 In Obese Subjects
A Randomized, Double-Blind, Outpatient, Placebo-Controlled, Dose Titration Study Of Gastrointestinal Tolerability Of Pf 05212389 (Oap-189) In Obese Subjects
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
This study examines whether a gradual increase of dose improves the gastrointestinal tolerability (nausea and vomiting) of PF05212389
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2011
Shorter than P25 for phase_1 obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedNovember 17, 2011
November 1, 2011
3 months
March 14, 2011
November 11, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
- Incidence, severity and duration of nausea and vomiting collected as adverse events.
Day 1 to day 28
Secondary Outcomes (4)
- 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
Study Arms (6)
Cohort 1
EXPERIMENTALCohort 2
EXPERIMENTALCohort 3
EXPERIMENTALCohort 4
EXPERIMENTALCohort 5
EXPERIMENTALCohort 6
ACTIVE COMPARATORInterventions
QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose.
Eligibility Criteria
You may qualify if:
- Obesity
You may not qualify if:
- Diabetes mellitus (type 1 or type 2) Heart failure Eating disorders Psychiatric disorders History of suicide attempt History of pancreatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 14, 2011
First Posted
November 17, 2011
Study Start
April 1, 2011
Primary Completion
July 1, 2011
Study Completion
August 1, 2011
Last Updated
November 17, 2011
Record last verified: 2011-11