To evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme \[CYP\]3A inhibitor) on the pharmacokinetics (PK) of olinciguat
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
Oral Tablet
Oral Capsule
PPD
Austin, Texas, United States
Maximum Observed Plasma Concentration (Cmax) of olinciguat
Time frame: Predose and up to 8 days post first olinciguat dose
Area under the plasma concentration time curve from time zero (predose) extrapolated to infinity (AUCinf)
Time frame: Predose and up to 8 days post first olinciguat dose
Number of subjects with ≥1 treatment-emergent adverse event (TEAE) in Period 1 vs Period 2
Time frame: 51 days post first olinciguat dose
Cmax of Itraconazole
Time frame: First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days)
Area under the concentration-time curve during a dosing interval (AUCtau) for itraconazole and hydroxy-itraconazole
Time frame: Period 2 (Period 2 duration can be up to 13 days) predose and up to 24 hour after 2nd olinciguat dose
Cmax of hydroxy-Itraconazole
Time frame: First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days)
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