A Study of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants

This open-label, randomised, four-way crossover, single dose study (n=16) aimed to investigate the safety, tolerability, and pharmacokinetics of different oral thin film (OTF) formulations of esketamine for sublingual administration in healthy participants.

The study was conducted by Janssen Research & Development, LLC in Belgium. Participants were required to have a body mass index (BMI) between 20.0 and 28.0 kg/m^2, be non-smokers, and meet other inclusion criteria. Exclusion criteria included various health conditions such as cardiac arrhythmias, diabetes mellitus, and epilepsy. The study involved four treatment sequences where participants received different OTF formulations of (S)-ketamine in each period, with a washout period between each treatment period.

The primary outcome measures included maximum plasma concentration (Cmax) and various pharmacokinetic parameters, while secondary outcome measures included vital signs, electrocardiogram (ECG) abnormalities, laboratory parameters, and adverse events. The study was completed on August 10, 2020, with a total enrolment of 16 participants.

Topic Healthy Subjects
Compound Ketamine
Country Belgium
Visit trial
Status Completed
Results Published No
Start date 19 June 2020
End date 10 August 2020
Phase Phase I
Design Open
Type Interventional
Generation Second
Participants 15
Sex All
Age 18- 50
Therapy No

Trial Details

The purpose of the study in healthy participants is to characterize the plasma pharmacokinetic (PK) profile of different single dose Oral Thin Film (OTF) (S)-ketamine formulations administered sublingually.

NCT Number NCT04300621

Sponsors & Collaborators

Janssen-Cilag
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Data attribution

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