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Completed

NCT Number: NCT05387759

A Thorough QT Study of Aticaprant (JNJ-67953964) 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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Aticaprant Supratherapeutic Dose

Drug

Aticaprant supratherapeutic dose capsule will be administered orally.

Other names: JNJ-67953964

Aticaprant Therapeutic Dose

Drug

Aticaprant therapeutic dose capsule will be administered orally.

Other names: JNJ-67953964

Placebo

Drug

Placebo will be administered orally.

moxifloxacin

Drug

Moxifloxacin capsule will be administered orally.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 24, 2022
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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