This study is to evaluate the effect of multiple doses of itraconazole, the potent cytochrome P450 enzymes (CYP3A) inhibitor, on the pharmacokinetics of PF-06648671 following a single dose administration in healthy subject.
Based on in vitro data, PF-06648671 was predominantly metabolized by CYP3A and therefore there is a potential risk that PF-06648671 PK will be affected by co-administered drugs that can inhibit CYP3A activity. This is a clinical drug interaction study to evaluate this potential drug interaction in human. In this study, healthy volunteers will take a single dose of 25 mg PF-06648671 in period 1 followed by at least 7 day washout. In period 2, same subjects will take 200 mg itraconazole oral solution once a day for 3 days, followed by co-administration of 200 mg oral solution and a single dose of 25 mg PF-06648671 on day 4 which are dosed approximately one hour apart with itraconazole is given first. The PF-06648671 PK will be collected 0-48 hours after dose in period 1 and 0-240 hrs in period 2. Safety will also be monitored throughout both periods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Subjects will receive a single dose of PF-06648671 25 mg oral suspension on day 1 in period 1 and a single dose on Day 4 in period 2.
Subjects will receive itraconazole 200 mg oral solution once a day for 14 days in period 2
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States
Maximum Observed PF-06648671 Plasma Concentration (Cmax)
Camx after single dose of 25 mg PF-06648671 in period 1 and period 2
Time frame: 0-48 hours in period 1 and 0-240 hours in period 2 following single dose PF-06648671
Time to Reach Maximum Observed Plasma concentration (Tmax)
Tmax following single doses of PF-06648671 in period 1 and period 2
Time frame: 0-48 hours in period 1 and 0-240 hours in period 2
Area Under the Curve From Time Zero to Extrapolated Infinite Time in Plasma (AUCinf)
AUCinf following single doses of PF-06648671 in period 1 and period 2
Time frame: 0-48 hours in period 1 and 0-240 hours in period 2
Area Under the Curve from Time Zero to Last Quantifiable Plasma Concentration (AUClast)
AUClast following single doses of PF-06648671 in period 1 and period 2
Time frame: 0-48 hours in period 1 and 0-240 hours in period 2
Plasma Decay Half-life (t1/2)
t1/2 following single doses of PF-06648671 in period 1 and period 2
Time frame: 0-48 hours in period 1 and 0-240 hours in period 2
Apparent Oral Clearance (CL/F)
CL/F following single doses of PF-06648671 in period 1 and period 2
Time frame: 0-48 hours in period 1 and 0-240 hours in period 2
Apparent Volume of Distribution (Vz/F)
Vz/F following single doses of PF-06648671 in period 1 and period 2
Time frame: 0-48 hours in period 1 and 0-240 hours in period 2
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