Healthy volunteers and Narcolepsy
Conditions
Sponsors
Osawa Masahiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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) 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (All Part), Pharmacokinetic (All Part), Compound concentration in cerebrospinal fluid (Part C only), Pharmacodynamic (Part F only) | — |
Contacts
Public ContactCenter Medical
Ono Pharmaceutical Co.,LTD
Outcome results
None listed