HealthyPhase 1NCT05387759
A Thorough QT Study of Aticaprant (JNJ-67953964) in Healthy Adult Participants
A Phase 1 study testing Aticaprant Supratherapeutic Dose, Aticaprant Therapeutic Dose and Moxifloxacin in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aticaprant Supratherapeutic Dose, Aticaprant Therapeutic Dose and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 30 May 2022to 4 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Aticaprant Supratherapeutic Dose, Aticaprant Therapeutic Dose, Placebo, Moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aticaprant Supratherapeutic DoseDrug
Also called JNJ-67953964
Aticaprant supratherapeutic dose capsule will be administered orally.
Aticaprant Therapeutic DoseDrug
Also called JNJ-67953964
Aticaprant therapeutic dose capsule will be administered orally.
PlaceboDrug
Placebo will be administered orally.
MoxifloxacinDrug
Moxifloxacin capsule will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Aticaprant Supratherapeutic Dose; Drug: Aticaprant Therapeutic Dose; Drug: Placebo; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in QTc at Each Time Point
Change from baseline in QTc at each time point will be reported.
Measured: Baseline up to Day 4
Secondary outcomes (8)
Maximum Observed Concentration (Cmax) of Aticaprant
Cmax is defined as the maximum observed plasma concentration of aticaprant and it's metabolite.
Measured: Predose up to 72 hours postdose (up to Day 4)
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.
Measured: 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])
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.
Measured: 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])
AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time of aticaprant.
Measured: Predose up to 72 hours postdose (up to Day 4)
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.
Measured: Up to Day 4
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.
Measured: Up to Day 4
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.
Measured: Up to Day 4
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.
Measured: Up to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start30 May 2022
- Primary completion4 Oct 2022
- Study completion4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387759
- Sponsor's protocol ID
- CR109186
- Other IDs
- 2021-002618-15, 67953964MDD1001
- Status last verified
- Apr 2025
- First submitted
- 20 May 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05387759
- Acronym / sponsor ID
- CR109186
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 May 2022 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 4 Oct 2022 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Experimental | Drug: Aticaprant Supratherapeutic Dose, Drug: Aticaprant Therapeutic Dose, Drug: Placebo, Drug: MoxifloxacinHealthy 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. |
| Treatment Sequence 2 | Experimental | Drug: Aticaprant Supratherapeutic Dose, Drug: Aticaprant Therapeutic Dose, Drug: Placebo, Drug: MoxifloxacinHealthy 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. |
| Treatment Sequence 3 | Experimental | Drug: Aticaprant Supratherapeutic Dose, Drug: Aticaprant Therapeutic Dose, Drug: Placebo, Drug: MoxifloxacinHealthy 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. |
| Treatment Sequence 4 | Experimental | Drug: Aticaprant Supratherapeutic Dose, Drug: Aticaprant Therapeutic Dose, Drug: Placebo, Drug: MoxifloxacinHealthy 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aticaprant Supratherapeutic DoseAlso: JNJ-67953964Aticaprant supratherapeutic dose capsule will be administered orally. | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
| Aticaprant Therapeutic DoseAlso: JNJ-67953964Aticaprant therapeutic dose capsule will be administered orally. | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
| PlaceboPlacebo will be administered orally. | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
| MoxifloxacinMoxifloxacin capsule will be administered orally. | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
Primary outcome
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.
8 secondary outcomes
Maximum Observed Concentration (Cmax) of Aticaprant
Time frame: 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)
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)
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)
Number of Participants With Adverse Events (AEs)
Time frame: Up to Day 4
Number of Participants with AEs of Special Interest (AESI)
Time frame: Up to Day 4
Number of Participants With Change in Vital Signs
Time frame: Up to Day 4
Number of Participants With Change in Laboratory Values
Time frame: Up to Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aticaprant Supratherapeutic Dose, Aticaprant Therapeutic Dose and Moxifloxacin in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in QTc at Each Time Point (time frame: Baseline up to Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.