Status:
COMPLETED
Safety and Pharmacokinetic Study of Inhaled Esketamine in Healthy Volunteers
Lead Sponsor:
Celon Pharma SA
Collaborating Sponsors:
National Center for Research and Development, Poland
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
Detailed 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 dos...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2018
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03407872
Start Date
December 9 2017
End Date
June 19 2018
Last Update
July 12 2018
Active Locations (1)
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1
BioResearch Group Sp. z o.o.
Kajetany, Poland