NCT03298906

A Study to Assess the Effect of Ticlopidine on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants

A Fixed-sequence, Open-label Study to Assess the Effect of Ticlopidine on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 58 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effects of ticlopidine on the pharmacokinetics (PK) of intranasally administered esketamine.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Esketamine	Participants will self-administer one intranasal spray of 14 mg esketamine at Time 0 and again 5 minutes later on Day 1, a total dose of 56 mg in Treatment Period 1 and 2.
DRUG	Ticlopidine	Participants will receive 250 mg ticlopidine tablets orally twice daily on Day -9 through Day 1 in Treatment Period 2.

Timeline

• Start date: 2017-09-26
• Primary completion: 2017-11-27
• Completion: 2017-11-27
• First posted: 2017-10-02
• Last updated: 2025-04-27

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study