SGS Life Science Services
Antwerp, 2060, Belgium
NCT Number: NCT04300621
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.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 1
Antwerp, 2060, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive (S)-ketamine administered sublingually through OTF 1.
Participants will receive (S)-ketamine administered sublingually through OTF 2.
Participants will receive (S)-ketamine administered sublingually through OTF 3.
Participants will receive (S)-ketamine administered sublingually through OTF 4.
Time frame: Up to 24 hours
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 will be reported.
Time frame: Up to 24 hours
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: Day 1
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) will be reported.
Time frame: Day 1 and 2
Number of participants with clinically significant abnormalities in ECG will be reported.
Time frame: Day 1 and 2
Number of participants with clinically significant abnormalities in laboratory parameters (Hematology, Clinical chemistry and routine analysis) will be reported.
Time frame: Up to Day 7
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.
Janssen Research & Development, LLC
Industry
An Open-label, Randomized, Four-way Crossover, Single Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Different Oral Thin Film (S)-Ketamine Formulations for Sublingual Administration in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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