NCT05387759

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Aticaprant Supratherapeutic Dose	Aticaprant supratherapeutic dose capsule will be administered orally.
DRUG	Aticaprant Therapeutic Dose	Aticaprant therapeutic dose capsule will be administered orally.
DRUG	Placebo	Placebo will be administered orally.
DRUG	Moxifloxacin	Moxifloxacin capsule will be administered orally.

Timeline

• Start date: 2022-05-30
• Primary completion: 2022-10-04
• Completion: 2022-10-04
• First posted: 2022-05-24
• Last updated: 2025-04-27

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study