Safety and Pharmacokinetic Study of Inhaled Esketamine in Healthy Volunteers

Celon Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo DPI; Drug: Esketamine DPI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03407872

01KET2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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,
• Blood drawn within 30 days prior to inclusion to the study (more or equal to 300mL),
• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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63 participants in 4 patient groups, including a placebo group

PART A

Experimental group

Description:

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

Treatment:

Drug: Esketamine DPI

Drug: Esketamine DPI

Drug: Esketamine DPI

PART B

Experimental group

Description:

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

Treatment:

Drug: Esketamine DPI

Drug: Esketamine DPI

Drug: Esketamine DPI

PART C

Experimental group

Description:

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

Treatment:

Drug: Esketamine DPI

Drug: Esketamine DPI

Drug: Esketamine DPI

PART C placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo DPI