PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, 9728 NZ, Netherlands
NCT Number: NCT05236868
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Groningen, 9728 NZ, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Seltorexant will be administered orally as a tablet and as an intravenous infusion of 14C-seltorexant.
Other names: JNJ-42847922
Time frame: Up to Day 4
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
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
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
Cmax of Seltorexant will be reported.
Time frame: Up to Day 4
Tmax of Seltorexant will be reported.
Time frame: Up to Day 4
Apparent terminal elimination half-life is calculated as 0.693/ lambda(z).
Time frame: Screening (up to -21 days) up to Day 7
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.
Janssen Research & Development, LLC
Industry
An Open-Label, Single-Dose Study to Assess the Absolute Oral Bioavailability and Pharmacokinetics of JNJ-42847922 (Seltorexant) Administered as Oral Tablet and an Intravenous Microdose of 14C-seltorexant in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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