Safety and Pharmacokinetic Study of Inhaled Esketamine in Healthy Volunteers

• Status: Completed
• Trial end date: 2018-06-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Celon Pharma SA
• Collaborators: National Center for Research and Development, Poland; The National Centre for Research and Development, Poland
• Treatments: Esketamine

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).