Study of PF 04965842 Effect on MATE1/2K Activity in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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.
    

Intervention name(s): Metformin; PF-04965842
Intervention type(s): Drug; Drug
Intervention description(s): Commercially available metformin (GLUCOPHAGE®) as 500 mg tablets.; PF 04965842 100 mg tablets
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin; Abrocitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Phase 1, randomized, 2 way crossover, open label study of the effect of PF 04965842 on metformin PK in healthy adult participants. The effect of PF 04965842 on N1 methylnicotinamide (NMN) PK and its correlation to the effect on metformin PK will also be assessed.
A total of approximately 12 healthy male and/or female participants will be enrolled in the study so that approximately 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
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase 1; Metformin; Atopic dermatitis