The purpose of this study is to characterize the plasma pharmacokinetic (PK) profile following the single ascending dose (SAD) levels of an (S)-ketamine oral solution for sublingual administration in healthy participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
17
Single dose of JNJ-54135419 oral solution will be administered sublingually.
SGS Life Science Services
Antwerp, Belgium
Plasma Concentrations of (S)-ketamine
Observed plasma concentrations of (S)-ketamine will be reported.
Time frame: Predose, 1 minute (min), 3 min, 5 min, 10 min, 15 min, 30 min, 40 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose
Plasma Concentrations of Nor-(S)-ketamine
Observed plasma concentrations of nor-(S)-ketamine will be reported.
Time frame: Predose, 1 minute (min), 3 min, 5 min, 10 min, 15 min, 30 min, 40 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose
Number of Participants with Vital Sign Abnormalities
Number of participants with vital signs (heart rate \[HR\], systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\]) abnormalities will be reported.
Time frame: Up to 4 Weeks
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment.
Time frame: Up to 4 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.