A Single and Multiple Dose Study of DSP-9632P

JRCT ID: jRCT2071210088

Registered date:30/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Levodopa-induced dyskinesia in Parkinson's disease
• Date of first enrollment: 29/10/2021
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Subjects receive DSP-9632P or placebo transdermally.

Outcome(s)

Primary Outcome

Safety endpoints: Adverse events, Clinical Laboratory tests, Vital signs, 12-lead electrocardiogram, Skin irritation at application site, Columbia Suicide Severity Rating Scale
Pharmacokinetics endpoints: Pharmacokinetics parameters

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Subject who fulfills the following age and other criteria in each part.
a. Part A Japanese healthy adult male subject between 20-45 years of age (inclusive) at the time of consent.
b. Part B Japanese healthy adult male subject between 20-45 years of age (inclusive) at the time of consent.
c. Part C Non-Asian healthy adult male subject between 20-45 years of age (inclusive) at the time of consent.
d. Part D Japanese healthy elderly male and female subject >= 65 years of age at the time of consent.
2) Subject who is fully informed and understands the objectives, procedures, anticipated drug effects/pharmacological action and risks of the study and who voluntarily provides written consent to participate in the study.
3) Subject's body weight must be between 50.0 kg and 100.0 kg and body mass index (BMI) must be at least 16.0 kg/m2 but no more than 32.0 kg/m2 at screening.
4) Subject who is able to comply with the study requirements, including physical examination, assessments, and reporting symptoms.
5) Subject with a partner of childbearing potential must agree to practice abstinence, consistent with lifestyle or to use acceptable birth control from signing informed consent to 30 days after the last study drug administration.

Exclude criteria

1. Subject with a clinically significant history of cardiovascular, hepatic, renal, endocrine, gastrointestinal, hematological, respiratory, psychiatric, or neurologic disease, determined by the investigator.
2. Subject with a history of epilepsy, convulsions, unexplained syncope or other unexplained loss of consciousness (except a single incident), or head trauma with loss of consciousness lasting more than 5 minutes.
3. Subject with a clinically significant abnormal 12-lead ECG or a screening 12-lead ECG for safety assessment that demonstrates any one of the following: heart rate > 100 bpm or < 50 bpm, QRS interval > 120 msec, QTcF > 450 msec (males) or > 470 msec (females) or PR interval > 220 msec.
4. Subject with dermatosis or skin abnormality (eg, dermatitis, eczema, or dyschromatosis) at application sites.
5. Subject with a history of drug allergy or skin allergy.
6. Subject with a known sensitivity to any transdermal patch.
7. Subject with a history of drug abuse or narcotic abuse, or a positive urine drug screening at screening visit or Day -1.
8. Subject who has a positive immunology at screening.
9. Subject with any clinically significant abnormal clinical laboratory value (hematology test, serum chemistry test, urinalysis, coagulation test, lipid test, or thyroid test) determined by the investigator at screening.
10. Subject with a history of excessive alcohol consumption (roughly defined as drinking at least 1.3 L of beer or 360 mL of Japanese sake per day) within 6 months prior to screening visit or a positive breath alcohol test at screening or Day -1.
11. Subject with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid amplification test between Day -8 and Day -1, or clinical symptoms suggestive of infection with SARS-CoV-2.
12. Subject who ordinarily drinks large quantities of caffeinated beverages (coffee, tea, green tea, cola, tonic drink, etc.) (approximately 1.8 L daily or more).
13. Subject with a history of tobacco dependency or has used tobacco or nicotine within 30 days prior to the initial study drug administration (including pipe, cigar, patch, inhaler, or gum).
14. Subject who has previously received DSP-9632P or tandospirone citrate.
15. Subject who has participated in any clinical study and received any investigational drug within 90 days prior to screening visit, or who is currently participating in another clinical trial.
16. Subject who has a disorder or history of a condition that may interfere with drug metabolism or excretion including clinically significant abnormality of the hepatic or renal systems.
17. Subject who has experienced significant blood loss or donated blood (>= 400 mL) within 90 days prior to the initial study drug administration 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.
18. Subject with a history of hospitalization within 45 days prior to screening visit (except hospitalization for tests).
19. Subject who answers yes to Suicidal Ideation Items 4 or 5 on the C-SSRS on Day -1.
20. Subject who has used prescription or non-prescription drugs within 14 days or 5 half-lives of the drug (whichever is longer) prior to the initial study drug administration.
21. Subject who has used vitamins, or dietary or herbal supplements within 14 days prior to the initial study drug administration.
22. Subject who is a staff member or the relative of a staff member.
23. Subject who is in the opinion of the investigator unsuitable in any other way to participate in this study.

Related Information

• Primary Sponsor: Nakamura Hiroki