Clinical Pharmacology Unit
Merksem, 2170, Belgium
NCT Number: NCT05387759
The purpose of this study is to assess the effects of aticaprant on QT/ QT interval corrected for heart rate (HR) (QTc) intervals and electrocardiogram (ECG) morphology at therapeutic and supratherapeutic exposures in healthy adult participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Merksem, 2170, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Aticaprant supratherapeutic dose capsule will be administered orally.
Other names: JNJ-67953964
Aticaprant therapeutic dose capsule will be administered orally.
Other names: JNJ-67953964
Placebo will be administered orally.
Moxifloxacin capsule will be administered orally.
Time frame: Baseline up to Day 4
Change from baseline in QTc at each time point will be reported.
Time frame: Predose up to 72 hours postdose (up to Day 4)
Cmax is defined as the maximum observed plasma concentration of aticaprant and it's metabolite.
Time frame: Predose up to 72 hours postdose (up to Day 4)
Tmax is the actual sampling time to reach the maximum observed plasma concentration of aticaprant.
Time frame: Predose up to 72 hours postdose (up to Day 4)
AUC (0-last) is the area under the plasma concentration-time curve from time 0 to the time of the last measurable (non-below quantification limit) concentration of aticaprant.
Time frame: Predose up to 72 hours postdose (up to Day 4)
AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time of aticaprant.
Time frame: Up to Day 4
Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.
Time frame: Up to Day 4
Number of participants with AESIs will be reported. Pruritus and severe diarrhea is considered to be an AESI.
Time frame: Up to Day 4
Number of participants with change in vital signs will be reported. Body temperature, blood pressure, and pulse/heart rate (HR) measurements will be assessed.
Time frame: Up to Day 4
Number of participants with change in laboratory parameters will be reported. Hematology, serum chemistry, and routine urinalysis will be assessed.
Janssen Research & Development, LLC
Industry
A Randomized, Double-blind, Placebo- and Positive-controlled, Single-dose, 4-way Crossover Study to Evaluate the Effects of Aticaprant (JNJ-67953964) on Electrocardiogram Intervals in Healthy Adult 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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