NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071220019

Registered date:29/06/2022

OP-2024-002 Study

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedParkinson's disease
Date of first enrollment06/07/2022
Target sample size24
Countries of recruitment
Study typeInterventional
Intervention(s)In each cohort, OP-2024 will be administered orally in single doses of 1, 2, 4, and 6 capsules, respectively.

Outcome(s)

Primary OutcomeSafety
Secondary OutcomePharmacokinetics

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 40age old
GenderMale
Include criteria1) Healthy Japanese male. 2) Those with age >= 18 to <= 40 years. 3) Those with BMI >= 18.5 to < 25.0. 4) Those who have provided voluntary written consent to participate in the study.
Exclude criteria1) Those with a history of allergies to investigational drug ingredients, drugs, or foods 2) Those who are undergoing treatment for, or have a history of, respiratory, circulatory, central nervous system, gastrointestinal, hepatic, renal, hematopoietic, or endocrine disorders that affect pharmacokinetics 3) Other protocol defined exclusion criteria could apply

Related Information

Contact

Public contact
Name Department of Clinical Development
Address 36F St.Luke&#039;s Tower 8-1, Akashi-cho, Chuo-ku, Tokyo, Japan Tokyo Japan 104-6591
Telephone +81-3-6740-7701
E-mail chiken@ohara-ch.co.jp
Affiliation OHARA Pharmaceutical Co.,Ltd.
Scientific contact
Name Fumi Taguchi
Address 36F St.Luke&#039;s Tower 8-1, Akashi-cho, Chuo-ku, Tokyo, Japan Tokyo Japan 104-6591
Telephone +81-3-6740-7701
E-mail chiken@ohara-ch.co.jp
Affiliation OHARA Pharmaceutical Co.,Ltd.