A pharmacokinetic study of NPC-15 Tablet (for adult use)

Phase 1

• Conditions: Sleep-onset difficulty associated with mild cognitive impairment or dementia

• Registration Number: JPRN-jRCT2071220113
• Lead Sponsor: Eto Takashi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

(1) Japanese healthy male subjects aged from 18 to 40 years at the time of obtaining informed consent, or elderly Japanese healthy male subjects aged from 65 to 80 years at the time of obtaining informed consent.(for NPC-15 2.5 mg Elderly Group)
(2) Subjects with BMI of 17.6 kg/m2 or more and less than 30.0 kg/m2 at the time of screening as well as on Day -1.
(3) Subjects of whom the time of sleep onset is from 21:00 to 25:00 at night and the time of wakeup is from 5:00 to 9:00 in the morning during one week before the study drug administration.
(4) Subjects who volunteered for participation in the study by their free will, and of whom the written informed consent was obtained.
(5) Subjects who are able to comply with the requirements for the study.

Exclusion Criteria

(1) Subjects who have a past history of hypersensitivity or allergy to melatonin or ramelteon.
(2) Subjects with concurrent or a past history of diseases that may affect pharmacokinetic and safety evaluation.
(3) Subjects with alcohol dependence or with its past history.
(4) Subjects with positive results on drug abuse test (urine drug test) or with a past experience to have used illicit drugs.
(5) Subjects who participated in a study for an unapproved medicinal product within 16 weeks prior to the start of study drug administration or in a study for an approved medicinal product within 12 weeks prior to the start of study drug administration, and received other investigational drugs (including placebo).
(6) Subjects who performed the following blood donation or blood collection
- At least 200 mL of whole blood collection within 4 weeks prior to the start of study drug administration
- At least 400 mL of whole blood collection within 12 weeks prior to the start of study drug administration
- Blood components donation within 2 weeks prior to the start of study drug administration
(7) Subjects who show positive result in any of the tests for HCV antibody, HBs antigen, HIV antigen/antibody, serological test for syphilis or PCR test for COVID-19 infection.
(8) Subjects who took any medicinal products or supplements within 2 weeks prior to the start of study drug administration
(9) Subjects who have smoked within 24 weeks prior to the start of study drug administration, or who are in the environment of passive smoking on a daily basis.
(10)Other subjects who deemed inappropriate for participation in the study by the investigators.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Serum melatonin concentration<br>- Pharmacokinetic parameters

Secondary Outcome Measures

Name	Time	Method
- Adverse events and adverse drug reactions<br>- Laboratory test values<br>- Vital signs<br>- 12-lead electrocardiography