NIPH Clinical Trials Search

A phase I clinical trial of KSP-0930

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Narcolepsy type 1
Date of first enrollment	15/05/2026
Target sample size	262
Countries of recruitment
Study type	Interventional
Intervention(s)	KSP-0930 suspension or tablets will be administered orally to participants in single or multiple doses.

Outcome(s)

Primary Outcome	- Incidence of adverse events and adverse drug reactions - Concentrations and pharmacokinetic parameters of KSP-0930
Secondary Outcome	- Ratio of pharmacokinetic parameters of KSP-0930

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 65age old
Gender	Both
Include criteria	- At the time of informed consent, male aged >=18 and =<45 years or females aged >=50 and <65 years at least 12 months after the last menstrual period. - Japanese participants with a BMI >=18.5 to <25 kg/m2 or Caucasian participants with a BMI >=18.5 to <30 kg/m2. - Males who body weight >=50 to <90 kg and females who body weight >=45 to <90 kg.
Exclude criteria	- Participants with abnormal findings on medical examination, vital signs, or 12-lead ECG, judged by the principal investigator or subinvestigator to be clinically significant.