This is a drug interaction study to evaluate the PF-06751979 at steady state on the pharmacokinetics of oral midazolam single doses in fixed sequences including single dose midazolam alone in period 1 followed by multiple doses of 100 mg PF-06751979 once a day for 11 days with single dose midazolam co-administered on Day 10 in period 2
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
a single oral dose of 2 mg midazolam
multiple oral doses of PF-06751979 100 mg a day
Pfizer Clinical Research Unit
Brussels, Belgium
midazolam Area Under the Curve from time 0 to last quantifiable concentration (AUClast) in Period 1
the plasma midazolam AUC from 0 to tlast (time of last quantifiable concentration) when a single oral midazolam dose given alone
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hrs post-dose
midazolam Cmax on Day 1 in Period 1
the midazolam Cmax when single oral midazolam dose given alone
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hrs post-dose
midazolam Area Under the Curve from time 0 to infinite (AUCinf) in Period 1
the plasma midazolam AUC from 0 to infinity when a single oral midazolam dose given alone
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 hrs post-dose
midazolam AUClast in Period 2
the plasma midazolam AUC from 0 to tlast (time of the last quantifiable concentration) when a single oral midazolam given in presence of steady state PF-06751979
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hrs post-dose
midazolam Cmax in Period 2
the midazolam Cmax when a single oral midazolam given in presence of steady state PF-06751979
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hrs post-dose
midazolam AUCinf in Period 2
the plasma midazolam AUC from 0 to infinity when a single oral midazolam given in presence of steady state PF-06751979
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48 hrs post-dose
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