A Thorough QT Study of Aticaprant (JNJ-67953964) in Healthy Adult Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05387759
• Other study ID #: CR109186
• Secondary ID: 2021-002618-1567
• Status: Completed
• Phase: Phase 1
• Start date: May 30, 2022
• Est. completion date: October 4, 2022

Study information

• Verified date: October 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 4, 2022
• Est. primary completion date: October 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Aticaprant Supratherapeutic Dose
Aticaprant supratherapeutic dose capsule will be administered orally.
• Aticaprant Therapeutic Dose
Aticaprant therapeutic dose capsule will be administered orally.
• Placebo
Placebo will be administered orally.
• Moxifloxacin
Moxifloxacin capsule will be administered orally.

Locations

Country	Name	City	State
Belgium	Clinical Pharmacology Unit	Merksem

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in QTc at Each Time Point	Change from baseline in QTc at each time point will be reported.	Baseline up to Day 4
Secondary	Maximum Observed Concentration (Cmax) of Aticaprant	Cmax is defined as the maximum observed plasma concentration of aticaprant and it's metabolite.	Predose up to 72 hours postdose (up to Day 4)
Secondary	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.	Predose up to 72 hours postdose (up to Day 4)
Secondary	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.	Predose up to 72 hours postdose (up to Day 4)
Secondary	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.	Predose up to 72 hours postdose (up to Day 4)
Secondary	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.	Up to Day 4
Secondary	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.	Up to Day 4
Secondary	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.	Up to Day 4
Secondary	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.	Up to Day 4