CompletedPhase 1ketamine
Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly and and Healthy Younger Adult Participants
Sponsored by Janssen Research & Development, LLC
NCT ID
NCT02345148
Target Enrollment
16 participants
Start Date
2014-12
Est. Completion
2015-01
About This Study
The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in elderly participants (greater than equal to \[\>=\] 75 years of age) and younger healthy adult participants (18 to 55 years of age, inclusive).
Conditions Studied
Interventions
- •Esketamine
Eligibility
Age:18 Years - N/A
Healthy Volunteers:Yes
View full eligibility criteria
Inclusion Criteria: * For Cohort 1, be a man or woman, \>= 75 years of age who are either healthy or who 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 less than 8 percent; degenerative joint disorders and osteoporosis; kidney function decline appropriate for age. Inclusion of participants with other chronic, well-controlled and stable conditions to Cohort 1 should be reviewed and agreed between the Investigator and the Sponsor * For Cohort 2, be a man or woman, 18 to 55 years of age, inclusive * For women of childbearing potential in Cohort 2, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day -1 * If a man, must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the study drug * Body mass index (BMI) (weight \[kg\]/height\^2 \[m\]\^2) between 18 and 32 kg/m\^2 (inclusive), and body weight not less than 50 kg Exclusion Criteria: * Diagnosed with a current or previous psychiatric disorder including but not limited to psychotic, bipolar, major depressive, or anxiety disorder * Clinically significant medical illness * Severe renal impairment * Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center (Day -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
Study Locations (1)
Merksem, Belgium