Clinical trial NCT05387759: A Thorough QT Study of Aticaprant (JNJ-67953964) in Healthy Adult Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and admission to the study center on Day -1 of the first treatment period. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable
* Body mass index (BMI; weight \[kilograms {kg}/ height square \[meter square {m\^2}\]) between 18 and 30.0 kg/m\^2 (inclusive), and body weight not less than 50 kg at screening
* All female participants must have a negative serum pregnancy test (Beta-human chorionic gonadotropin \[Beta-hCG\]) at screening and a negative urine pregnancy test at admission to the study site on Day -1 of the first treatment period
* A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of at least 90 days after receiving the last dose of study intervention
* Non-smoker (not smoked for 3 months prior to screening)

Exclusion Criteria:

* History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the investigator considers should exclude the participant
* History of additional risk factors for Torsade de Pointes or the presence of a family history of short QT syndrome, long QT syndrome, sudden unexplained death at a young age (less than/equal to 40 years), drowning or sudden infant death syndrome in a first degree relative (that is, biological parent, sibling, or child)
* Any skin condition likely to interfere with electrocardiographic electrode placement or adhesion
* Breast implant or a history of thoracic surgery likely to cause abnormality of the electrical conduction through thoracic tissues
* History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)

Primary outcomes:
measure: Change from Baseline in QTc at Each Time Point
timeFrame: Baseline up to Day 4
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax) of Aticaprant
timeFrame: Predose up to 72 hours postdose (up to Day 4)
measure: Time To Reach The Maximum Observed Concentration of Aticaprant (Tmax)
timeFrame: Predose up to 72 hours postdose (up to Day 4)
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to last of Aticaprant (AUC [0-last])
timeFrame: Predose up to 72 hours postdose (up to Day 4)
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time of Aticaprant (AUC[0-infinity])
timeFrame: Predose up to 72 hours postdose (up to Day 4)
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to Day 4
measure: Number of Participants with AEs of Special Interest (AESI)
timeFrame: Up to Day 4
measure: Number of Participants With Change in Vital Signs
timeFrame: Up to Day 4
measure: Number of Participants With Change in Laboratory Values
timeFrame: Up to Day 4
Other outcomes:
Locations:
city: Merksem
country: Belgium
facility: Clinical Pharmacology Unit
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: