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

JRCT ID: jRCT2071220113

Registered date:02/03/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Sleep-onset difficulty associated with mild cognitive impairment or dementia
• Date of first enrollment: 15/03/2023
• Target sample size: 30
• Study type: Interventional

Intervention(s)

- NPC-15 1.25 mg Group
A single oral administration of NPC-15 (melatonin) 1.25 mg in a fasted condition (for 1 day)
- NPC-15 2.5 mg Group
A single oral administration of NPC-15 (melatonin) 2.5 mg in a fasted condition and a single oral administration of NPC-15 2.5 mg after meal (for a total of 2 days)
- NPC-15 5 mg (5 mg x 1) Group
A single oral administration of NPC-15 (melatonin) 5 mg (one tablet of 5 mg Tablet) in a fasted condition (for 1 day)
- NPC-15 5 mg (2.5 mg x 2) Group
A single oral administration of NPC-15 (melatonin) 5 mg (2 tablets of 2.5 mg Tablet) in a fasted condition (for 1 day)
- NPC-15 2.5 mg Elderly Group
A single oral administration of NPC-15 (melatonin) 2.5 mg in a fasted condition (for 1 day)

Outcome(s)

Primary Outcome

- Serum melatonin concentration
- Pharmacokinetic parameters

Secondary Outcome

- Adverse events and adverse drug reactions
- Laboratory test values
- Vital signs
- 12-lead electrocardiography

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Male

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Eto Takashi
• Secondary ID(s): Nil known