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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00799006 |
PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics following a single oral dose.
Condition | Intervention | Phase |
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Overweight |
Drug: Placebo Drug: PF-04620110 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Safety Study |
Official Title: | A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Escalating Oral Doses Of PF-04620110 In Otherwise Healthy Overweight And Obese Subjects |
Estimated Enrollment: | 18 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator |
Drug: Placebo
Subjects will be given placebo or PF-04620110
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PF-04620110: Experimental |
Drug: PF-04620110
A single oral dose of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned and the period of the cross-over for that cohort. Initial planned doses are 0.3-30 mg but may be modified based on emerging PK and safety data.
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | B0961001 |
Study First Received: | November 25, 2008 |
Last Updated: | December 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00799006 |
Health Authority: | United States: Food and Drug Administration |
Single Ascending Dose Study in Overweight subjects |
Body Weight Signs and Symptoms Obesity Overweight Healthy |