Healthy Participants Clinical Trial
Official title:
A PHASE 1, OPEN-LABEL, FIXED SEQUENCE 2-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSES OF ITRACONAZOLE ON THE PHARMACOKINETICS OF A SINGLE DOSE OF PF-06651600 IN HEALTHY PARTICIPANTS
This study will estimate the impact of a strong CYP3A4 inhibitor (itraconazole) on the
pharmacokinetics of an investigational product (PF-06651600) in healthy adult participants.
This is an open-label, fixed sequence two period study with healthy participants that will
receive a single dose of PF-06651600 alone and co-administered with multiple doses of
itraconazole at a single center.
Participants will be screened within 28 days of the first dose of the investigational
products and if entry criteria are met, the participant will report to the clinic on the day
before the Day 1 visit. On Day 1 of Period 1, each participant will receive a 30 mg dose of
PF-06651600 and PK samples will be collected for 48 hours. In Period 2, participants will
receive itraconazole solution from Day 1-5. On Day 4 of Period 2 the participant will receive
30 mg of PF-06651600 with the itraconazole. PK samples will be collected up to 48 hours after
the PF-06651600 dose. Participants will be confined for a total of 9 days in the clinic. The
participant will be followed up by phone contact.
n/a
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