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

April 25, 2025 updated by: Janssen Research & Development, LLC

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Merksem, Belgium, 2170
        • Clinical Pharmacology Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Placebo
Placebo will be administered orally.
Drug: Aticaprant Supratherapeutic Dose
Aticaprant supratherapeutic dose capsule will be administered orally.
Other Names:
  • JNJ-67953964
Drug: Aticaprant Therapeutic Dose
Aticaprant therapeutic dose capsule will be administered orally.
Other Names:
  • JNJ-67953964
Drug: Moxifloxacin
Moxifloxacin capsule will be administered orally.
Experimental: 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.
Drug: Placebo
Placebo will be administered orally.
Drug: Aticaprant Supratherapeutic Dose
Aticaprant supratherapeutic dose capsule will be administered orally.
Other Names:
  • JNJ-67953964
Drug: Aticaprant Therapeutic Dose
Aticaprant therapeutic dose capsule will be administered orally.
Other Names:
  • JNJ-67953964
Drug: Moxifloxacin
Moxifloxacin capsule will be administered orally.
Experimental: 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.
Drug: Placebo
Placebo will be administered orally.
Drug: Aticaprant Supratherapeutic Dose
Aticaprant supratherapeutic dose capsule will be administered orally.
Other Names:
  • JNJ-67953964
Drug: Aticaprant Therapeutic Dose
Aticaprant therapeutic dose capsule will be administered orally.
Other Names:
  • JNJ-67953964
Drug: Moxifloxacin
Moxifloxacin capsule will be administered orally.
Experimental: 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.
Drug: Placebo
Placebo will be administered orally.
Drug: Aticaprant Supratherapeutic Dose
Aticaprant supratherapeutic dose capsule will be administered orally.
Other Names:
  • JNJ-67953964
Drug: Aticaprant Therapeutic Dose
Aticaprant therapeutic dose capsule will be administered orally.
Other Names:
  • JNJ-67953964
Drug: Moxifloxacin
Moxifloxacin capsule will be administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in QTc at Each Time Point
Time Frame: Baseline up to Day 4
Change from baseline in QTc at each time point will be reported.
Baseline up to Day 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Concentration (Cmax) of Aticaprant
Time Frame: Predose up to 72 hours postdose (up to Day 4)
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)
Time To Reach The Maximum Observed Concentration of Aticaprant (Tmax)
Time Frame: Predose up to 72 hours postdose (up to Day 4)
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)
Area Under the Plasma Concentration-Time Curve From Time Zero to last of Aticaprant (AUC [0-last])
Time Frame: Predose up to 72 hours postdose (up to Day 4)
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)
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time of Aticaprant (AUC[0-infinity])
Time Frame: Predose up to 72 hours postdose (up to Day 4)
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)
Number of Participants With Adverse Events (AEs)
Time Frame: Up to Day 4
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
Number of Participants with AEs of Special Interest (AESI)
Time Frame: Up to Day 4
Number of participants with AESIs will be reported. Pruritus and severe diarrhea is considered to be an AESI.
Up to Day 4
Number of Participants With Change in Vital Signs
Time Frame: Up to Day 4
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
Number of Participants With Change in Laboratory Values
Time Frame: Up to Day 4
Number of participants with change in laboratory parameters will be reported. Hematology, serum chemistry, and routine urinalysis will be assessed.
Up to Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 4, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR109186
  • 2021-002618-15 (EudraCT Number)
  • 67953964MDD1001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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