This is a drug-drug interaction study in volunteers to evaluate the effect of ritonavir or cobicistat on the pharmacokinetics (PK) of PBI-200.
This is an open-label, single-sequence, three-period drug-drug interaction study in healthy male and female volunteers to evaluate the effect of a potent CYP3A inhibitor, ritonavir or cobicistat, on the single dose PK of orally administered PBI-200. It is expected that co-administration of ritonavir or cobicistat with PBI-200 will increase the exposure of PBI 200.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
PBI-200 is a TRK inhibitor
Ritonavir is a potent CYP3A inhibitor
Cobicistat is a potent CYP3A inhibitor
Celerion, Inc.
Tempe, Arizona, United States
Maximum Plasma Concentration [C(max)] of PBI-200
Maximum (peak) plasma drug concentration
Time frame: 11 days
Area Under the Concentration-Time Curve (AUC) from time zero to the time of the last measurable concentration [AUC(0-t)]
AUC, calculated using linear up / log down trapezoidal method from time zero to time t, where t is the time of the last measurable concentration.
Time frame: 11 days
AUC from time zero to infinity [AUC(0-inf)]
AUC from time zero to infinity, AUC(0-inf) = AUC(0-t) + Ct/kel, where kel is the terminal rate constant and Ct is the last measurable concentration.
Time frame: 11 days
Terminal elimination half-life [T(1/2)]
Apparent terminal elimination half-life, calculated as ln(2)/kel.
Time frame: 11 days
Incidence, frequency and severity of adverse events (AEs)
Time frame: 45 days
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