This study will evaluate the safety and tolerability, pharmacokinetic, and pharmacodynamic profile, and drug-drug interaction (DDI) of casdatifan in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
Investigational Site
Groningen, Netherlands
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 21.5 Weeks
Number of Participants With Abnormal Changes From Baseline in Laboratory Parameter Values
Time frame: Baseline; Up to 21.5 Weeks
Number of Participants With Abnormal Changes from Baseline in Vital Sign Values
Time frame: Baseline; Up to 21.5 Weeks
Maximum Observed Plasma Concentration (Cmax) of casdatifan
Time frame: multiple timepoints up to approximately 21.5 Weeks
Area Under the Plasma Concentration Time Curve From Hour 0 to the Last Sample With Measurable Plasma Concentrations (AUClast) of casdatifan
Time frame: multiple timepoints up to approximately 21.5 Weeks
Time of Occurrence of Cmax (tmax) of casdatifan
Time frame: multiple timepoints up to approximately 21.5 Weeks
Apparent Terminal Elimination Rate Constant (λz) of casdatifan
Time frame: multiple timepoints up to approximately 21.5 Weeks
Terminal Half-Life (t1/2) of casdatifan
Time frame: multiple timepoints up to approximately 21.5 Weeks
Area Under the Plasma Concentration Time Curve From Hour 0 to Infinity (AUCinf) of casdatifan
Time frame: multiple timepoints up to approximately 21.5 Weeks
Apparent Volume of Distribution of casdatifan
Time frame: multiple timepoints up to approximately 21.5 Weeks
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Apparent Total Body Clearance of casdatifan
Time frame: multiple timepoints up to approximately 21.5 Weeks
Maximum Observed Plasma Concentration (Cmax) of midazolam and 1 hydroxymidazolam
Time frame: multiple timepoints up to approximately 21.5 Weeks
Area Under the Plasma Concentration Time Curve From Hour 0 to the Last Sample With Measurable Plasma Concentrations (AUClast) of midazolam and 1 hydroxymidazolam
Time frame: multiple timepoints up to approximately 21.5 Weeks
Time of Occurrence of Cmax (tmax) of midazolam and 1 hydroxymidazolam
Time frame: multiple timepoints up to approximately 21.5 Weeks
Apparent Terminal Elimination Rate Constant (λz) of midazolam and 1 hydroxymidazolam
Time frame: multiple timepoints up to approximately 21.5 Weeks
Terminal Half-Life (t1/2) of midazolam and 1 hydroxymidazolam
Time frame: multiple timepoints up to approximately 21.5 Weeks
Area Under the Plasma Concentration Time Curve From Hour 0 to Infinity (AUCinf) of midazolam and 1 hydroxymidazolam
Time frame: multiple timepoints up to approximately 21.5 Weeks
Apparent Volume of Distribution of midazolam and 1 hydroxymidazolam
Time frame: multiple timepoints up to approximately 21.5 Weeks
Apparent Total Body Clearance of midazolam and 1 hydroxymidazolam
Time frame: multiple timepoints up to approximately 21.5 Weeks