Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly Japanese, and Healthy Younger Adult Japanese Subjects



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:20 - Any
Updated:12/14/2016
Start Date:August 2016
End Date:December 2016
Contact:Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email:JNJ.CT@sylogent.com

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An Open-Label, Single-Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Elderly (>=65 Years of Age) Japanese, and Healthy Younger Adult Japanese Subjects (20 to 55 Years of Age, Inclusive)

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of
intranasally administered esketamine in elderly Japanese subjects and healthy younger adult
Japanese subjects.


Inclusion Criteria:

- A) Cohort 1: Be a Japanese man or woman greater than or equal to (>=) 65 years of age
with at least 4 subjects >= 70 years of age, who was born in Japan, who has resided
outside of Japan for >= 10 years, with parents and maternal and paternal grandparents
who are of Japanese ethnicity. Subjects must be either healthy or present with
stable, well-controlled, chronic conditions which frequently occur in the elderly,
such as: Hyperlipidemia,Controlled hypertension, Impaired fasting glucose, impaired
glucose tolerance, or type 2 diabetes mellitus controlled with diet, and/or metformin
monotherapy, dipeptidyl peptidase-4 (DPP-4) inhibitor monotherapy or a combination of
metformin and DPP-4 inhibitor, who have glycated hemoglobin (HbA1c) levels <8 percent
(%), Degenerative joint disorders and osteoporosis; B) Cohort 2: Be a healthy
Japanese man or woman 20 to 55 years of age, inclusive, who was born in Japan, who
has resided outside of Japan for >= 10 years, and has parents and maternal and
paternal grandparents who are of Japanese ethnicity. Each subject will be matched to
an elderly subject in Cohort 1 by gender and body weight (+/- 20%) using data
collected during Screening

- Signed an informed consent document indicating they understand the purpose of and
procedures required for the study and are willing to participate in the study

- Willing to adhere to the prohibitions and restrictions specified in this protocol

- Cohort 2: If a woman, must have a negative serum beta-human chorionic gonadotropin
(hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 of
the treatment period. Women using contraceptives must agree to use an additional
birth control method during the study and for 1 month after receiving the last dose
of study drug

- If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction

Exclusion Criteria:

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

- History of or current clinically significant medical illness including (but not
limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,
coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid
abnormalities, significant pulmonary disease, including bronchospastic respiratory
disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease,
neurologic or psychiatric disease, infection, or any other illness that the
investigator considers should exclude the subject or that could interfere with the
interpretation of the study results. Elderly subjects in Cohort 1 with stable,
well-controlled, chronic conditions which frequently occur in the elderly as outlined
in Inclusion Criteria 1 will be permitted to participate in the study

- 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 before the first study drug administration as
deemed appropriate by the investigator

- History of moderate or severe use disorder according to Diagnostic and Statistical
Manual of Mental Disorders (5th edition) (DSM-5) criteria within 1 year before
screening or positive test result(s) for alcohol and/or drugs of abuse (such as
barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at
screening and Day -1 of the treatment period
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