Title
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
Phase
Phase 1Lead Sponsor
Celon Pharma SAStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Healthy VolunteersIntervention/Treatment
Esketamine DPI Esketamine DPI Esketamine DPI ...Study Participants
63The 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.
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.
Participants will receive different number of consecutive Esketamine DPI inhalations, consider as a single dose. There will be dose escalation between cohorts.
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.
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.
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.
6 cohorts will receive single dose of Esketamine DPI administered with dose escalation between cohorts.
4 cohorts will receive single dose of Esketamine DPI administered with dose escalation between cohorts.
4 cohorts will receive multiple dose of Esketamine DPI in two weeks' time administered with dose escalation between cohorts.
4 cohorts will receive multiple dose of matching placebo in two weeks' time.
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).
