The purpose of this study is to determine the absolute bioavailability of seltorexant in healthy participants following a single oral dose of seltorexant and an intravenous (IV) infusion dose of 14C-seltorexant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Seltorexant will be administered orally as a tablet and as an intravenous infusion of 14C-seltorexant.
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, Netherlands
Absolute Bioavailability
Absolute bioavailability is calculated as the ratio of dose normalized area under the plasma drug concentration-time curve (AUC) of oral and intravenous (IV) administration.
Time frame: Up to Day 4
Area Under the Plasma Analyte Concentration Versus Time Curve of Seltorexant from Time Zero to Infinite time (AUC [0-Infinity])
AUC (0-infinity) is defined as the area under the plasma analyte concentration versus time curve of seltorexant from time zero to infinite time.
Time frame: Up to Day 4
Area Under the Plasma Analyte Concentration Versus Time Curve of Seltorexant from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last])
AUC (0-Last) is defined as area under the plasma analyte concentration versus time curve from time zero to time of the last measurable (non- below quantifiable limit \[BQL\]) concentration.
Time frame: Up to Day 4
Maximum Observed Plasma Analyte Concentration (Cmax) of Seltorexant
Cmax of Seltorexant will be reported.
Time frame: Up to Day 4
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Seltorexant
Tmax of Seltorexant will be reported.
Time frame: Up to Day 4
Apparent Terminal Elimination Half-life (t1/2) of Seltorexant
Apparent terminal elimination half-life is calculated as 0.693/ lambda(z).
Time frame: Up to Day 4
Number of Participants with Adverse Events (AEs)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: Screening (up to -21 days) up to Day 7