CompletedPhase 1ketamine
Safety and Pharmacokinetic Study of Inhaled Esketamine in Healthy Volunteers
Sponsored by Celon Pharma SA
NCT ID
NCT03407872
Target Enrollment
63 participants
Start Date
2017-12-09
Est. Completion
2018-06-19
About This Study
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 Studied
Interventions
- •Esketamine DPI
- •Esketamine DPI
- •Esketamine DPI
- •Placebo DPI
Eligibility
Age:18 Years - 55 Years
Healthy Volunteers:Yes
View full eligibility criteria
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).
Study Locations (1)
BioResearch Group Sp. z o.o.
Kajetany, Poland