Recent Updates
Recently added Catalysts

Aticaprant Supratherapeutic Dose

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Apr 27, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Aticaprant Supratherapeutic Dose · 1 trial · 1 indication

Phase 1 1
NCT05387759A Thorough QT Study of Aticaprant (JNJ-67953964) in Healthy Adult ParticipantsHealthy
COMPLETED60 Analytics
PHASE1COMPLETED
A Thorough QT Study of Aticaprant (JNJ-67953964) in Healthy Adult Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline in QTc at Each Time Point
Baseline up to Day 4

Change from baseline in QTc at each time point will be reported.

Secondary Endpoints

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)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Sequence 1EXPERIMENTALHealthy 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 2EXPERIMENTALHealthy 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 3EXPERIMENTALHealthy 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 4EXPERIMENTALHealthy 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.

Interventions

NameTypeDescription
Aticaprant Supratherapeutic DoseDRUGAticaprant supratherapeutic dose capsule will be administered orally.
Aticaprant Therapeutic DoseDRUGAticaprant therapeutic dose capsule will be administered orally.
PlaceboDRUGPlacebo will be administered orally.
MoxifloxacinDRUGMoxifloxacin capsule will be administered orally.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 clini...

Countries:Belgium
Unlock Eligibility Criteria

Frequently asked questions about Aticaprant Supratherapeutic Dose

What is Aticaprant Supratherapeutic Dose used for?

Aticaprant Supratherapeutic Dose is an investigational small molecule being studied in healthy adult participants. It is being evaluated in a clinical trial to assess its effects on cardiac repolarization, specifically through a thorough QT study. The drug is in Phase 1 clinical development and is not approved for any medical use.

Who makes Aticaprant Supratherapeutic Dose?

Aticaprant Supratherapeutic Dose is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical research on this investigational small molecule in healthy volunteers.

What phase is Aticaprant Supratherapeutic Dose in?

Aticaprant Supratherapeutic Dose is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a completed Phase 1 trial that enrolled 60 healthy adult participants.

What clinical trials is Aticaprant Supratherapeutic Dose in?

Aticaprant Supratherapeutic Dose is associated with one completed clinical trial, NCT05387759, titled "A Thorough QT Study of Aticaprant (JNJ-67953964) in Healthy Adult Participants." This Phase 1 study was conducted in Belgium and enrolled 60 healthy adults aged 18 years and older.

Is Aticaprant Supratherapeutic Dose the same as JNJ-67953964?

Yes, Aticaprant Supratherapeutic Dose is also known as JNJ-67953964. The clinical trial NCT05387759 uses this alternative name in its title, referring to the same investigational small molecule being developed by Johnson & Johnson.