Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Healthy Han Chinese, Korean, Japanese, and Caucasian Participants and the Effects of Rifampin on the Pharmacokinetics of Intranasally Administered Esketamine



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:20 - 55
Updated:3/28/2019
Start Date:February 26, 2016
End Date:May 28, 2016

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An Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Han Chinese, Korean, Japanese, and Caucasian Subjects and the Effects of Rifampin on the Pharmacokinetics of Intranasally Administered Esketamine

The purpose of this study is to evaluate the pharmacokinetics of intranasally administered
esketamine in healthy Han Chinese, Korean, Japanese, and Caucasian participants and to
evaluate the effects of rifampin on the pharmacokinetics of intranasally administered
esketamine in healthy Caucasian participants.


Inclusion Criteria:

- For Cohort 1: healthy Han Chinese participants 20 to 55 years of age, inclusive, who
have resided outside of China for no more than 10 years and have parents and maternal
and paternal grandparents who are of Han Chinese ethnicity For Cohort 2: healthy
Korean participants 20 to 55 years of age, inclusive, who have resided outside of
Korea for no more than 10 years and have parents and maternal and paternal
grandparents who are of Korean ethnicity For Cohort 3: healthy Japanese participants
20 to 55 years of age, inclusive, who have resided outside of Japan for no more than
10 years and have parents and maternal and paternal grandparents who are of Japanese
ethnicity For Cohort 4: healthy Caucasian participants 20 to 55 years of age,
inclusive Participants must be within +/-7 years and +/-20 percent (%) of the combined
mean age and mean body weight at Screening, respectively, of Cohort 1, Cohort 2, and
Cohort 3

- Body mass index (BMI; weight [kilogram]/height^2 [m]^2) between 18 and 30 kilogram per
meter square (kg/m^2), inclusive, and a body weight not less than 47 kilogram (kg)

- If a woman, must have a negative serum beta-human chorionic gonadotropin (beta-hCG)
pregnancy test at Screening

- If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during the study and for 1 month after receiving the last dose of study
drug

- Creatinine clearance more than equal to (>=)80 milliliters per minute (mL/min) based
on Cockroft-Gault equation

Exclusion Criteria:

- Current significant psychiatric disorder including but not limited to psychotic,
bipolar, major depressive, or anxiety disorder

- Clinically significant abnormal values for hematology, clinical chemistry, or
urinalysis at Screening or Day -1 of Period 1 as deemed appropriate by the
investigator

- Clinically significant abnormal physical examination, vital signs, or 12 lead
electrocardiogram (ECG) at Screening or Day -1 of Period 1 as deemed appropriate by
the investigator

- History of drug or alcohol abuse disorder within the past 1 year, or a reason to
believe a participant has such a history

- Regular use of intranasal tobacco powder within the past 1 year, or a reason to
believe a participant has such a history
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