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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
SGS Life Science Services
Antwerp, Belgium
Maximum Plasma Concentration (Cmax)
Maximum plasma concentration will be reported.
Time frame: Up to 24 hours
Area Under the Plasma Concentration-time Curve from Time 0 To Time Of the Last Quantifiable Concentrations [AUC(0-last)]
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentrations will be reported.
Time frame: Up to 24 hours
Area Under the Plasma Concentration-Time Curve from Time 0 to Infinite Time [AUC(0-infinity)]
Area under the plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUC(last) and C(last)/lambda, in which C(last) is the last observed quantifiable concentrations will be reported.
Time frame: Up to 24 hours
Number of Participants with Clinically Significant Abnormalities in Vital sign (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP])
Number of participants with clinically significant abnormalities in blood pressure (Systolic Blood Pressure \[SBP\], Diastolic Blood Pressure \[DBP\]) will be reported.
Time frame: Day 1
Number of Participants with Clinically Significant Abnormalities in Vital Sign (Heart Rate)
Number of participants with clinically significant abnormalities in vital sign (heart rate) will be reported.
Time frame: Day 1
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs)
Number of participants with clinically significant abnormalities in ECG will be reported.
Time frame: Day 1 and 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will receive (S)-ketamine administered sublingually through OTF 4.
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Number of participants with clinically significant abnormalities in laboratory parameters (Hematology, Clinical chemistry and routine analysis) will be reported.
Time frame: Day 1 and 2
Number of Participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: Up to Day 7