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

NCT ID: NCT05387759

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-30
• Study Completion Date: 2022-10-04

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Sequence 1

Healthy participants will receive single oral dose of Aticaprant (Dose 1) (Treatment A) in Treatment Period 1, followed by Moxifloxacin (Dose 2) (Treatment D) in Treatment Period 2, followed by Aticaprant (Dose 3) (Treatment B) in Treatment Period 3 and then placebo (Treatment C) in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7-15 days between each treatment period.

Group Type: EXPERIMENTAL

Aticaprant Supratherapeutic Dose

Intervention Type: DRUG

Aticaprant supratherapeutic dose capsule will be administered orally.

Aticaprant Therapeutic Dose

Intervention Type: DRUG

Aticaprant therapeutic dose capsule will be administered orally.

Placebo

Intervention Type: DRUG

Placebo will be administered orally.

Moxifloxacin

Intervention Type: DRUG

Moxifloxacin capsule will be administered orally.

Treatment Sequence 2

Healthy participants will receive single oral dose of Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment C in Treatment Period 3 and then Treatment D in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7-15 days between each treatment period.

Group Type: EXPERIMENTAL

Aticaprant Supratherapeutic Dose

Intervention Type: DRUG

Aticaprant supratherapeutic dose capsule will be administered orally.

Aticaprant Therapeutic Dose

Intervention Type: DRUG

Aticaprant therapeutic dose capsule will be administered orally.

Placebo

Intervention Type: DRUG

Placebo will be administered orally.

Moxifloxacin

Intervention Type: DRUG

Moxifloxacin capsule will be administered orally.

Treatment Sequence 3

Healthy participants will receive single oral dose of Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment D in Treatment Period 3 and then Treatment A in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7-15 days between each treatment period.

Group Type: EXPERIMENTAL

Aticaprant Supratherapeutic Dose

Intervention Type: DRUG

Aticaprant supratherapeutic dose capsule will be administered orally.

Aticaprant Therapeutic Dose

Intervention Type: DRUG

Aticaprant therapeutic dose capsule will be administered orally.

Placebo

Intervention Type: DRUG

Placebo will be administered orally.

Moxifloxacin

Intervention Type: DRUG

Moxifloxacin capsule will be administered orally.

Treatment Sequence 4

Healthy participants will receive single oral dose of Treatment D in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment A in Treatment Period 3 and then Treatment B in Treatment Period 4, on Day 1 of each treatment period. There will be a wash-out period up to 7 to 15 days between each treatment period.

Group Type: EXPERIMENTAL

Aticaprant Supratherapeutic Dose

Intervention Type: DRUG

Aticaprant supratherapeutic dose capsule will be administered orally.

Aticaprant Therapeutic Dose

Intervention Type: DRUG

Aticaprant therapeutic dose capsule will be administered orally.

Placebo

Intervention Type: DRUG

Placebo will be administered orally.

Moxifloxacin

Intervention Type: DRUG

Moxifloxacin capsule will be administered orally.

Interventions

Aticaprant Supratherapeutic Dose

Aticaprant supratherapeutic dose capsule will be administered orally.

Intervention Type: DRUG

Aticaprant Therapeutic Dose

Aticaprant therapeutic dose capsule will be administered orally.

Intervention Type: DRUG

Placebo

Placebo will be administered orally.

Intervention Type: DRUG

Moxifloxacin

Moxifloxacin capsule will be administered orally.

Intervention Type: DRUG

Other Intervention Names

JNJ-67953964; JNJ-67953964

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2021-002618-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

67953964MDD1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR109186

Identifier Type: -

Identifier Source: org_study_id