CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
PF-04937319 400 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/NCT01044537
NCT01044537Phase 1Completed
CompareCT.gov

A Phase 1 Placebo-controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Escalating Oral Doses Of Pf-04937319 In Adult Subjects With Type 2 Diabetes Mellitus

Pfizer·interventional·Posted Jan 8, 2010·Updated Mar 10, 2017

In Brief

A Phase 1 clinical trial evaluating Placebo and PF-04937319 for Type 2 Diabetes Mellitus. Completed, enrolled 50 participants across 3 sites.

Detailed Summary

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04937319 following single escalating oral doses in adult subjects with Type 2 Diabetes Mellitus (T2DM).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 8, 2010
Enrollment StartFeb 1, 2010
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.5 years ago

Interventions

Placebodrug

Placebo to match PF-04937319 will be provided.

PF-04937319drug

The initial planned dosing schedule is: 10, 30, 100, 200, and 400 mg, with one cohort to be determined. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as a single oral dose as a powder-in-capsule (PIC) formulation. PF-04937319 will be supplied as 10 mg and 80 mg (and potentially 1 mg) PIC.