Safety and Pharmacokinetic Study of Inhaled Esketamine in Healthy Volunteers

NCT03407872 | Completed Phase 1

• 1 other identifier: 01KET2017
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• Cmax - maximum Esketamine plasma concentration

  The maximum concentration of the Esketamine in plasma after drug administration, obtained directly from the measured concentrations.

  up to 24 hours after each study drug administration in PART A, B and C of the study.

• AUC (0-24) - area under the Esketamine plasma concentration-time curve from time 0 to 24 hours after study drug administration

  The AUC(0-24) is a measure of total plasma exposure to the drug from time point zero to 24 hours after study drug administration.

  up to 24 hours after each study drug administration in PART A, B and C of the study.

• Number of inhalations needed to achieve the assumed Esketamine antidepressive plasma concentration.

  up to 24 hours after study drug administration in PART A

• Number of inhalations within dosing sequence needed to maintain the assumed Esketamine antidepressive plasma concentration.

  up to 24 hours after study drug administration in PART B

Secondary Outcomes (8)

• AUC (0-inf) - area under the Esketamine plasma concentration-time curve from time 0 to infinity time

  up to 24 hours after each study drug administration in PART A, B and C of the study.

• Tmax - time to reach maximum Esketamine plasma concentration

  up to 24 hours after each study drug administration in PART A, B and C of the study.

• Kel -elimination rate constant

  up to 24 hours after each study drug administration in PART A, B and C of the study.

• T1/2 - plasma elimination half-life for Esketamine

  up to 24 hours after each study drug administration in PART A, B and C of the study.

• Cmax - maximum Esnorketamine plasma concentration

  up to 24 hours after each study drug administration in PART A, B and C of the study.

Study Arms (4)

PART A

EXPERIMENTAL

6 cohorts will receive single dose of Esketamine DPI administered with dose escalation between cohorts.

Drug: Esketamine DPI

PART B

EXPERIMENTAL

4 cohorts will receive single dose of Esketamine DPI administered with dose escalation between cohorts.

Drug: Esketamine DPI

PART C

EXPERIMENTAL

4 cohorts will receive multiple dose of Esketamine DPI in two weeks' time administered with dose escalation between cohorts.

Drug: Esketamine DPI

PART C placebo

PLACEBO COMPARATOR

4 cohorts will receive multiple dose of matching placebo in two weeks' time.

Drug: Placebo DPI

Interventions

Esketamine DPI DRUG

Participants will receive different number of consecutive Esketamine DPI inhalations, consider as a single dose. There will be dose escalation between cohorts.

PART A

Placebo DPI DRUG

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.

PART C placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian female or male,
• Age: 18-55 years old, inclusive,
• Body-mass index (BMI): ≥18.5 kg/m\^2 and \<29.9 kg/m\^2
• Non-smoker and nonuser of tobacco products for at least 1 year before screening,
• Physical examination without any clinically relevant abnormality,
• Laboratory values not clinically significant,
• Volunteer (or his/her partner) of childbearing potential willingness to use acceptable forms of contraception.

You may not qualify if:

• Known allergy or hypersensitivity to ketamine or its derivates and/or to any study product excipients,
• Any known significant current or past acute or chronic disease or condition,
• Participation in other clinical trial within 90 days preceding the screening,
• Positive results from pregnancy test for female participants,
• Lactation in women participants,
• Hypotension or hypertension in medical history,
• Narcotic, alcohol addiction or abuse,
• Participant who adhere to a special diet (e.g. low calories, vegetarian).

Sponsors & Collaborators

• Celon Pharma SA: lead
• National Center for Research and Development, Poland: collaborator

Study Sites (1)

BioResearch Group Sp. z o.o.

Kajetany, Poland

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Only PART C will be double-blind.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 23, 2018
• Study Start: December 9, 2017
• Primary Completion: May 20, 2018
• Study Completion: June 19, 2018
• Last Updated: July 12, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)