CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 61 enrolled
Drug / intervention
PF-04937319 +1 moredrug
Likely dose
PF-04937319 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01272804
NCT01272804Phase 1Completed
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A Phase 1 Placebo-controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Escalating Oral Doses Of Pf-04937319 In Adult Patients With Type 2 Diabetes Mellitus (t2dm)

Pfizer·interventional·Posted Jan 10, 2011·Updated Feb 1, 2017

In Brief

A Phase 1 clinical trial evaluating PF-04937319 and Placebo for Diabetes Mellitus, Type 2 and NIDDM. Completed, enrolled 61 participants across 4 sites.

Detailed Summary

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-04937319 following multiple (14 days) escalating oral doses in patients with type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, NIDDM
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 10, 2011
Enrollment StartFeb 1, 2011
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.5 years ago

Interventions

PF-04937319drug

Subjects will be dosed with PF-04937319 for 14 days. The doses planned are 10, 30, 100 and 300 mg QD. All doses will be administered as tablets (10 and 100 mg strengths). In each Cohort, 9 patients will receive PF 04937319 and 3 will receive placebo. An additional cohort of 12 patients (9 active, 3 placebo) may be performed to explore a QD or BID dose. The dose for this additional cohort could be a dose already studied or a new dose that is within the exposure stopping criteria.

Placebodrug

Placebo to match PF-04937319 will be provided. Subjects will be dosed for 14 days. In each cohort 9 subjects will receive PF-04937319 and 3 will receive placebo.