ONO-2909-01:ONO-2909 Phase I study

JRCT ID: jRCT2071200073

Registered date:24/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy volunteers and Narcolepsy
• Date of first enrollment: 12/01/2021
• Target sample size: 138
• Study type: Interventional

Intervention(s)

1) Part A: Single Japanese Part
A single-dose, dose-escalation, placebo-controlled, double-blind, randomized, parallel-group study in healthy Japanese adult male subjects.
2) Part B (Japanese elderly single dose part)
A single-dose, placebo-controlled, double-blind, randomized, parallel-group study in elderly Japanese men and women.
3) Part C (Japanese Cerebrospinal Fluid Collection Part)
Single-dose, uncontrolled, open-label study in healthy Japanese adult male subjects.
4) Part D (Japanese Multiple dose part)
A multiple-dose, placebo-controlled, double-blind, randomized, parallel-group study in healthy Japanese adult male subjects.
5) Part E (Caucasian Multiple dose part)
A multiple oral dose, placebo-controlled, double-blind, randomized, parallel-group study in healthy male Caucasian subjects.
6) Part F (Japanese patients with narcolepsy part)
A multiple oral dose, placebo-controlled, double-blind, randomized, two-treatment, two-period crossover comparative study in Japanese patients with narcolepsy.

Outcome(s)

• Primary Outcome: Safety (All Part), Pharmacokinetic (All Part), Compound concentration in cerebrospinal fluid (Part C only), Pharmacodynamic (Part F only)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 74age old
• Gender: Both

Include criteria

<Japanese healthy adult males and elderly males/females,Caucasian healthy adult males>
1) Japanese healthy adult male subjects,Japanese elderly male or female subjects,Caucasian healthy adult male subjects
2) Age at the time of informed consent:18 to 45(Healthy adults),65 to 74(Elderly males/Elderly females)
3) BMI(at screening): 18.5 kg/m2 to less than 25.0 kg/m2/30.0 kg/m2(Japanese/Caucasian)
<Patients with narcolepsy>
1) Age at the time of informed consent:18 to 74
2) Body weight(at screening)>=40 kg
3) Diagnosis of narcolepsy based on the International Classification of Sleep Disorders,3rd edition(The International Classification of Sleep Disorders_3 rd edition,ICSD_3)(Type 1 or Type 2).For NT1,the subject has the HLAD_QB1 *06:02 gene.
4) Epworth Sleepiness Scale score:>=11

Exclude criteria

<All Participants>
1) Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease.
2) Subjects with current or with a history of severe allergy to drugs or foods
3) Subjects with current or with a history of drug or alcohol abuse
<Patients with narcolepsy>
1) Sleep disorders other than narcolepsy (Sleep apnea or Periodic limb movement disorder, etc)
2) Sleep_wake rhythm disorder due to external factors such as night work or irregular working hours

Related Information

• Primary Sponsor: Osawa Masahiro