JNJ-42847922
DrugJNJ-42847922 tablet will be administered orally.
Other names: Seltorexant
NCT Number: NCT04616677
The purpose of this study is to evaluate the pharmacokinetic of a single oral dose of JNJ-42847922 in adult participants with renal impairment compared with healthy participants with normal renal function.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 1
Orlando Clinical Research Center, Orlando, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-42847922 tablet will be administered orally.
Other names: Seltorexant
Time frame: Pre-dose, up to 96 hours post-dose (up to Day 5)
Cmax is defined as maximum observed plasma analyte concentration of JNJ-42847922 and its metabolites A and B.
Time frame: Pre-dose, up to 96 hours post-dose (up to Day 5)
AUC(0-Last) is defined as area under the plasma analyte concentration versus time curve from time 0 to time of last measurable concentration of JNJ-42847922 and its metabolites A and B.
Time frame: Pre-dose, up to 96 hours post-dose (up to Day 5)
AUC(0-infinity) is defined as the area under the plasma analyte concentration versus time curve from time 0 to infinite time of JNJ-42847922 and its metabolites A and B.
Time frame: Up to Day 5
An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
Janssen Research & Development, LLC
Industry
An Open-Label, Single-Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-42847922 in Adult Participants.
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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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