An open-label, fixed-sequence, 2-period study to investigate the effect of multiple oral doses of itraconazole on a single oral dose of PF-06700841 PK in healthy participants. The study will consist of two treatment periods in one fixed sequence.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
PF-06700841 oral tablets in 5mg and 25mg provided for a 30mg dose
200 mg oral solution administered as 20 milliliters(mL) (10 mg/mL)
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, United States
Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841
Time frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2
Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841
Time frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2
Maximum Observed Plasma Concentration (Cmax) of PF-06700841
Time frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2
Incidence of treatment-emergent adverse events (TEAE)
For male and women of non-childbearing potential (WONCBP), last phone call follow up is 28-35 days after last dose For women of childbearing potential (WOCBP), last phone call follow up is 60-65 days after last dose
Time frame: screening to last phone all follow up
Incidence of Serious Adverse Events(SAE), and AEs leading to Discontinuation
For male and women of non-childbearing potential (WONCBP), last phone call follow up is 28-35 days after last dose For women of childbearing potential (WOCBP), last phone call follow up is 60-65 days after last dose
Time frame: screening to last phone call follow up
The incidence of clinically significant abnormalities in vital signs
Time frame: screening, pre-dose and 3 hours post-dose on Day 1 in Period 1; Pre-dose on Day 1, 3 hours post-dose on Day 4 and prior to discharge on Day 7 in Period 2
The incidence of clinically significant abnormalities in electrocardiograms(ECG)
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Time frame: screening, pre-dose and 3 hours post-dose on Day 1 in Period 1; Pre-dose on Day 1, 3 hours post-dose on Day 4 and prior to discharge on Day 7 in Period 2
The incidence of clinically significant abnormalities in clinical laboratory values
Time frame: screening, Day -1 in Period 1 and prior to discharge in Period 2
Maximum plasma concentration(Cmax) of PF-06700841
Time frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2
Plasma (Tmax) time to reach Cmax of PF-06700841
Time frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2
Terminal elimination half-life (t1/2) of PF-06700841
Time frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2
Apparent clearance (CL/F) of PF-06700841
Time frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2
Apparent volume of distribution(Vz/F) of PF-06700841
Time frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2
Maximum plasma concentration(Cmax) of PF-06700841 major metabolite (M1)
Time frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2
Plasma (Tmax) time to reach Cmax of PF-06700841 major metabolite (M1)
Time frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2
Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841 major metabolite (M1)
Time frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2
Metabolite/parent ratio (M/P) of PF-06700841 major metabolite (M1)
Time frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2
Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 major metabolite (M1)
if data permit
Time frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2
Terminal elimination half-life (t1/2) of PF-06700841 major metabolite (M1)
if data permit
Time frame: Hour 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 in periods 1 and 2. Hour 72 in period 2