A Single Dose Study of DSP-0187

JRCT ID: jRCT2071210103

Registered date:26/12/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Narcolepsy
• Date of first enrollment: 05/01/2022
• Target sample size: 64
• Study type: Interventional
• Intervention(s): Subjects receive DSP-0187 or placebo orally.

Outcome(s)

Primary Outcome

Safety Endpoints: Adverse events, clinical laboratory tests, vital signs, body weight, ECG, C-SSRS, neurological
Pharmacokinetic Endpoints: Pharmacokinetics parameters

• Secondary Outcome: Karolinska Sleepiness Scale (KSS)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 50age old
• Gender: Male

Include criteria

1. Healthy Japanese adult male subject between 20 and 50 years of age (inclusive) at time of informed consent.
2. Subject who is fully informed of and understand the objectives, procedures, anticipated drug effects/pharmacological action and risks of the study and who voluntarily provide written consent to participate in the study.
3. Subject's body weight must be between 50.0 kg and 80.0 kg, and body mass index (BMI) is at least 18 kg/m2 but no more than 25 kg/m2.
4. Subject who is willing and able to comply with the study requirements, including laboratory tests and reporting symptoms.
5. Subject with female partner of childbearing potential must agree to adequate and reliable contraception (e.g. using condom or vasectomy for male and using contraceptive agents, diaphragm, intrauterine devices, or bilateral tubal ligation for female partner) from informed consent until at least 30 days after study drug administration.
6. Subject must possess an educational level and degree of understanding of Japanese that enables them to communicate suitably with the Investigators and study coordinator.

Exclude criteria

1. Subject with a history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, hematological, respiratory, psychiatric, neurologic disease, and who considered ineligible for the study by the Principal Investigator or Sub-Investigator.
2. Subject with a clinically significant abnormal standard 12-lead electrocardiogram (ECG) that may have jeopardized the subject's ability to complete the study or a screening standard 12-lead ECG that demonstrated any one of the following based on the investigator's interpretation: heart rate (HR) >100 bpm or <50 bpm, QRS >120 msec, QTcF >450 msec, or PR >200 msec.
3. Subject with a known sensitivity to any substance contained in the study formulation.
4. Subject with a history of drug allergy.
5. Subject with a history of substance abuse, drug abuse, or a positive urine drug screening at screening visit or clinic admission.
6. Subject with a positive immunology [Hepatitis B Surface Antigen, Hepatitis C Antibody, HIV Antigen/Antibody, Syphilis serological testing (Treponema pallidum assay, Rapid plasma reagin assay)] at screening.
7. Subject with any clinically significant abnormalities in clinical laboratory test (hematology, serum chemistry, urinalysis, lipid, coagulation) or neurological test determined by the Principal Investigator or Sub-Investigator at screening.
8. Subject with a history of excessive alcohol consumption (defined as drinking at least 1.3 L of beer or 360 mL of sake daily) within 6 months of screening visit.
9. Subject who drinks large quantities of caffeinated beverages (coffee, tea, green tea, cola, tonic drink, etc.) (approximately 1.8 L daily or more).
10. Subject with a history of tobacco dependency or subject who smoke a mean of more than 20 cigarettes daily.
11. Subject who had used tobacco or nicotine within 30 days prior to the initial study drug administration (including pipe, cigar, patch, chewing tobacco, spray, inhaler, or gum).
12. Subject who has previously received DSP-0187 in the study.
13. Subject with sleep-wake disorder (insomnia disorder, hypersomnolence disorder, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep-wake disorder etc.), or subject experienced sleep wake cycle disturbance with external factors such as irregular work hours.
14. Subject who answers "yes" to "Suicidal Ideation" Items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) on Day -1.
15. Subject with a disorder or history of a condition that may interfere with drug absorption, distribution, metabolism or excretion including clinically significant abnormality of the hepatic or renal systems defined by Common Terminology Criteria for Adverse Events v5.0 (CTCAE) grade 2 or higher, a history of malabsorption, or previous gastrointestinal surgery that could affect drug absorption or metabolism.
16. Subject who has experienced significant blood loss or donated blood (>400 mL) within 90 days or donated 200 mL of blood or more within 30 days prior to the initial study drug administration; has donated blood components within 14 days prior to the initial study drug administration or intends to donate blood components or blood within 30 days after the last study visit.
17. Subject who has received any investigational drug or who is currently participating or has participated in a clinical trial within 90 days prior to screening visit.
18. Subject with a history of hospitalization within 45 days prior to screening visit.
19. Subject who has used prescription or over-the-counter (OTC) medications within 14 days or 5 half-lives (whichever is longer) prior to the initial study drug administration.
20. Subject who has used dietary or herbal supplements within 14 days prior to the initial study drug administration.
21. Subject who consumed St. John's wort-containing foods or beverages within 14 days prior to the initial study drug administration.
22. Subject who consumed grapefruit- or Seville orange-containing foods or beverages within 7 days prior to the initial study drug administration.
23. Subject with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid amplification test on Part A Day -1 or Part B Day -1, or clinical symptoms suggestive of infection with SARS-CoV-2.
24. Subject who have been vaccinated within 1 week before Day 1 administration.
25. Subject who is a staff member or the relative of a staff member.
26. Subject who is in the opinion of the Principal Investigator or Sub-Investigator, unsuitable in any other way to participate in this study.

Related Information

• Primary Sponsor: Komiya Masafumi