PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, 9728 NZ, Netherlands
NCT Number: NCT04090086
The purpose of this study is to evaluate the effect of single and multiple dose (once daily for 7 days) oral JNJ-64417184 and JNJ-53718678 on the pharmacokinetic (PK) of single and multiple-dose (once daily for 7 days) oral JNJ 53718678 and JNJ-64417184, respectively when coadministered to healthy adult participants under fed conditions.
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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
JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.
JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.
Time frame: Day 2, 3, 4, 5 and 6: predose; Day 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose
Ctrough is defined as observed plasma analyte concentration just prior to the beginning of a dosing interval.
Time frame: Day 2, 3, 4, 5 and 6: predose; Day 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose
Ctrough is defined as observed plasma analyte concentration just prior to the beginning of a dosing interval.
Time frame: Day 1 and 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose
Cmax is defined as maximum observed plasma analyte concentration.
Time frame: Day 1 and 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose
Cmax is defined as maximum observed plasma analyte concentration.
Time frame: Up to 24 hours postdose
AUC24h is defined as AUC from time 0 to 24 hours postdose.
Time frame: Up to 24 hours postdose
AUC24h is defined as AUC from time 0 to 24 hours postdose.
Time frame: Up to 42 days
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Janssen Research & Development, LLC
Industry
A Phase 1, Open-label, Randomized, 3-way Crossover Study to Assess the Pharmacokinetic Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Subjects
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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