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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Aticaprant supratherapeutic dose capsule will be administered orally.
Aticaprant therapeutic dose capsule will be administered orally.
Placebo will be administered orally.
Clinical Pharmacology Unit
Merksem, Belgium
Change from Baseline in QTc at Each Time Point
Change from baseline in QTc at each time point will be reported.
Time frame: Baseline up to Day 4
Maximum Observed Concentration (Cmax) of Aticaprant
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)
Time To Reach The Maximum Observed Concentration of Aticaprant (Tmax)
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)
Area Under the Plasma Concentration-Time Curve From Time Zero to last of Aticaprant (AUC [0-last])
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)
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time of Aticaprant (AUC[0-infinity])
AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time of aticaprant.
Time frame: Predose up to 72 hours postdose (up to Day 4)
Number of Participants With Adverse Events (AEs)
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
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Moxifloxacin capsule will be administered orally.
Number of Participants with AEs of Special Interest (AESI)
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
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 Values
Number of participants with change in laboratory parameters will be reported. Hematology, serum chemistry, and routine urinalysis will be assessed.
Time frame: Up to Day 4