NCT03407872

Safety and Pharmacokinetic Study of Inhaled Esketamine in Healthy Volunteers

One-centre Safety and Pharmacokinetics Phase I Study of Inhaled Esketamine in Healthy Volunteers With Two Single Ascending Dose and One Double-blind Multiple Ascending Dose Parts

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Celon Pharma SA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The planned study is to determine the pharmacokinetic properties of Esketamine and safety assessment with inhaled Esketamine after different number of inhalations and different dosing sequences within three parts of the study.

Detailed description

This is to be one-centre, single ascending dose and double-blind placebo controlled multiple dose three part study of Esketamine DPI (dry powder inhaler) in healthy volunteers. PART A is a single dose, open-label part with Esketamine DPI inhalations administered with dose escalation between cohorts. PART B is a single dose, open-label part with Esketamine DPI inhalations administered in different dosing sequences with dose escalation between cohorts. PART C is a multiple dose, double-blind, placebo-controlled part with Esketamine DPI inhalations administered in different cycles of treatment (with four dosing sequences within two weeks) with dose escalation between cohorts. Participants in this part will be randomized to receive Esketamine DPI or placebo in 3:1 ratio. Pharmacokinetic properties and safety of Esketamine DPI will be determined following different number of inhalations in PART A, different dosing sequences in PART B and different cycles of treatment in PART C.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Esketamine DPI	Participants will receive different number of consecutive Esketamine DPI inhalations, consider as a single dose. There will be dose escalation between cohorts.
DRUG	Esketamine DPI	Participants will receive different dosing sequences of Esketamine DPI inhalations, consider as a single dose. There will be dose escalation between cohorts. Number of Esketamine DPI inhalations within a dosing sequence will be defined based on results from PART A of the study. Dose: very low, low, medium, high.
DRUG	Esketamine DPI	Participants will receive different cycle of treatment consisting of 4 dosing sequences administered within 2 weeks. There will be dose escalation between cohorts. Participants in this part will be randomized to receive Esketamine DPI or placebo in 3:1 ratio. Number of Esketamine DPI inhalations within a dosing sequence will be defined based on results from PART A and PART B of the study. Dose: very low, low, medium, high.
DRUG	Placebo DPI	Participants will receive different cycle of treatment consisting of 4 dosing sequences administered within 2 weeks. Participants in this part will be randomized to receive Esketamine DPI or placebo in 3:1 ratio. In each cohort, number of placebo inhalations within a dosing sequence will correspond to number of Esketamine DPI inhalations.

Timeline

• Start date: 2017-12-09
• Primary completion: 2018-05-20
• Completion: 2018-06-19
• First posted: 2018-01-23
• Last updated: 2018-07-12

Locations

1 site across 1 country: Poland