A Phase 1 interventional study of PF 05212389 or placebo and PF 05212389 or placebo in Obesity, sponsored by Pfizer. Withdrawn. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-11-17.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
This study examines whether a gradual increase of dose improves the gastrointestinal tolerability (nausea and vomiting) of PF05212389
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Obesity
Exclusion Criteria:
Diabetes mellitus (type 1 or type 2) Heart failure Eating disorders Psychiatric disorders History of suicide attempt History of pancreatitis
Drug: PF 05212389 or placebo
Drug: PF 05212389 or placebo
Drug: PF 05212389 or placebo
Drug: PF 05212389 or placebo
Drug: PF 05212389 or placebo
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.
QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose.
QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts
QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts
QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts
QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts
- Incidence, severity and duration of nausea and vomiting collected as adverse events.
Time frame: Day 1 to day 28
- 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
No study locations are listed for this record.
This study is withdrawn, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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