CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Metformin +1 moredrug
Likely dose
Metformin 500 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/NCT03796182
NCT03796182Phase 1Completed
CompareCT.gov

A PHASE 1, RANDOMIZED, 2-WAY CROSSOVER, OPEN LABEL STUDY TO ESTIMATE THE EFFECT OF PF-04965842 ON MATE1/2K ACTIVITY, USING METFORMIN AS A PROBE, IN HEALTHY PARTICIPANTS

Pfizer·interventional·Posted Jan 8, 2019·Updated Feb 5, 2020

In Brief

A Phase 1 clinical trial evaluating Metformin and PF-04965842 for Healthy. Completed, enrolled 12 participants across 1 site.

Detailed Summary

This is a Phase 1, randomized, 2 way crossover, open label study of the effect of PF-04965842 on metformin (a probe for MATE1/2K activity) PK in healthy adult participants. The effect of PF-04965842 on N1-methylnicotinamide (NMN; an endogenous biomarker for MATE1/2K) PK and its correlation to the effect on metformin PK will also be assessed. Participants will be randomized to 1 of 2 treatment sequences as described below. A total of 12 healthy male and/or female participants will be enrolled in the study so that 6 participants will be enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBelgium
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 8, 2019
Enrollment StartJan 10, 2019
Primary CompletionFeb 13, 2019
Study CompletionMar 12, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.5 years ago

Interventions

Metformindrug

Commercially available metformin (GLUCOPHAGE®) as 500 mg tablets.

PF-04965842drug

PF 04965842 100 mg tablets