Healthy Clinical Trial
Official title:
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
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.
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.
Participants who discontinue from the study may be replaced at the sponsor's discretion. The
replacement participant will receive the same treatment sequence as the participant who
discontinued.
Participants will be screened within 28 days of the first dose of investigational product.
Participants will report to the clinical research unit (CRU) the day prior to Day 1 (ie Day
-1) dosing in Period 1 for both treatment sequences. In both sequences, participants will
remain in the CRU for a total of 8 days and 7 nights (including Period 1 and Period 2). There
will be a minimum 4 day washout period between metformin dosing events. NMN and metformin PK
will be assessed in plasma and urine over 24 and 48 hours, respectively.
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