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

NCT ID: NCT02846519

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-26
• Study Completion Date: 2016-05-28

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Esketamine

Participants in Cohort 1 (Han Chinese participants), Cohort 2 (Korean participants) and Cohort 3 (Japanese participants ) will receive 100-microliter (mcL) spray of 14 percent (%) esketamine solution (14 milligram \[mg\]) into each nostril at Time 0 and 5 minutes later for a total dose of 56 milligram (mg) in Period 1.

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

100-mcL spray of 14% esketamine solution (14 mg) for a total dose of 56 mg.

Esketamine+Rifampin

Participants in Cohort 4 (Caucasian participants) will receive a 56-mg intranasal esketamine dose regimen on Day 1 in treatment period 1 followed by rifampin from Day -6 to Day -1 of treatment Period 2 and followed by 56-mg intranasal esketamine dose regimen on Day 1 in treatment period 2.

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

100-mcL spray of 14% esketamine solution (14 mg) for a total dose of 56 mg.

Rifampin

Intervention Type: DRUG

2 capsules (300 mg each) of rifampin.

Interventions

Esketamine

100-mcL spray of 14% esketamine solution (14 mg) for a total dose of 56 mg.

Intervention Type: DRUG

Rifampin

2 capsules (300 mg each) of rifampin.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Cypress, California, United States

Countries

United States

References

Perez-Ruixo C, Rossenu S, Zannikos P, Nandy P, Singh J, Drevets WC, Perez-Ruixo JJ. Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression. Clin Pharmacokinet. 2021 Apr;60(4):501-516. doi: 10.1007/s40262-020-00953-4. Epub 2020 Oct 31.

Reference Type: DERIVED

PMID: 33128208 (View on PubMed)

Other Identifiers

ESKETINTRD1008

Identifier Type: OTHER

Identifier Source: secondary_id

CR108128

Identifier Type: -

Identifier Source: org_study_id