A study in healthy male subjects to investigate whether administration of rifampicin can affect the fate in the body (amount and time of presence in the blood) of clazosentan
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
14
Continuous i.v. infusion of 15 mg/h of clazosentan for 3 h
Single i.v. dose of 600 mg rifampicin for 30 min
Single i.v infusion of 500 mL saline for 30 min
QPS Netherlands B.V.
Groningen, Netherlands
AUC from zero to time t of the last measured concentration above the limit of quantification
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: 24 hours post treatment infusion initiation
AUC from zero to infinity (AUC0-inf)
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: 24 hours post treatment infusion initiation
AUC from zero to 3 h (AUC0-3)
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: 24 hours post treatment infusion initiation
The maximum plasma concentration (Cmax)
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: 24 hours post treatment infusion initiation
Terminal half-life (t½)
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: 24 hours post treatment infusion initiation
Total body clearance (CL)
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: 24 hours post treatment infusion initiation
Volume of distribution at steady state (Vss)
The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles
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Time frame: 24 hours post treatment infusion initiation