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

NCT05387759 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1091862021-002618-1567953964MDD1001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Maximum Observed Concentration (Cmax) of Aticaprant

  Predose up to 72 hours postdose (up to Day 4)

• Time To Reach The Maximum Observed Concentration of Aticaprant (Tmax)

  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])

  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])

  Predose up to 72 hours postdose (up to Day 4)

• Number of Participants With Adverse Events (AEs)

  Up to Day 4

Study Arms (4)

Treatment Sequence 1

EXPERIMENTAL

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.

Drug: Aticaprant Supratherapeutic Dose; Drug: Aticaprant Therapeutic Dose; Drug: Placebo; Drug: Moxifloxacin

Treatment Sequence 2

EXPERIMENTAL

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.

Drug: Aticaprant Supratherapeutic Dose; Drug: Aticaprant Therapeutic Dose; Drug: Placebo; Drug: Moxifloxacin

Treatment Sequence 3

EXPERIMENTAL

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.

Drug: Aticaprant Supratherapeutic Dose; Drug: Aticaprant Therapeutic Dose; Drug: Placebo; Drug: Moxifloxacin

Treatment Sequence 4

EXPERIMENTAL

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.

Drug: Aticaprant Supratherapeutic Dose; Drug: Aticaprant Therapeutic Dose; Drug: Placebo; Drug: Moxifloxacin

Interventions

Aticaprant Supratherapeutic Dose DRUG

Aticaprant supratherapeutic dose capsule will be administered orally.

Also known as: JNJ-67953964

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

Aticaprant Therapeutic Dose DRUG

Aticaprant therapeutic dose capsule will be administered orally.

Also known as: JNJ-67953964

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

Placebo DRUG

Placebo will be administered orally.

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

Moxifloxacin DRUG

Moxifloxacin capsule will be administered orally.

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

MeSH Terms

Interventions

Aticaprant; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 24, 2022
• Study Start: May 30, 2022
• Primary Completion: October 4, 2022
• Study Completion: October 4, 2022
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)