Healthy Volunteers Clinical Trial
Official title:
An Open-label, Single-Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Intranasally Administered Esketamine in Healthy Japanese and Caucasian Subjects
The purpose of this Phase 1 study is to characterize the pharmacokinetic profile (what the body does to the medication) of esketamine when given by the intranasal route (through the nose) to healthy adult Japanese and Caucasian participants.
This is an open-label single-center study with 2 cohorts (groups). The study will consist of
a screening phase, a treatment phase, and a follow-up visit (9 to 13 days after the last
dose of the study drug). During the screening phase, participants will be evaluated to
determine if they meet the study eligibility criteria. A target of 14 healthy Japanese and
14 healthy Caucasian adult participants (20 to 55 years of age inclusive) will be enrolled
in Cohort 1 and Cohort 2, respectively.
The participants in each cohort will self-administer each of the 3 different single-dose
regimens of intranasal esketamine (Treatments A, B, and C) over the 3 treatment periods (ie,
1 treatment per period) in an open-label manner (both the investigator and the participant
knows which intervention the participant receives). The participants will be randomly (like
the toss of a coin) assigned to receive Treatment A and Treatment B in the first two periods
(ie, Treatment A in Period 1 and Treatment B in Period 2, or the reverse order). All
participants will receive Treatment C in Period 3. The regimens differ in the number of
sprays to achieve the total dose and the total esketamine dose administered.
Safety and tolerability will be evaluated throughout the study and will include assessment
of adverse events, targeted nasal examinations, laboratory tests, electrocardiogram,
physical examination, pulse oximetery, and vital signs.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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