NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2051200104

Registered date:24/12/2020

A Phase 1 Study of KK6483 in Healthy Male Volunteers

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedParkinson's disease
Date of first enrollment06/01/2021
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)A single oral administration of the investigational product, KK6483C in combination with the existing levodopa (LD)/carbidopa (CD)/entacapone (ET)

Outcome(s)

Primary OutcomePlasma drug concentration Pharmacokinetic parameters
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 45age old
GenderMale
Include criteria1) Those who have provided voluntary written consent to participate in the study 2) Men aged >= 20 to < 45 years at the time of informed consent. 3) Those with BMI >= 18.5 to < 25.0 at the time of preliminary test
Exclude criteria1) Those with present illness requiring treatment 2) Those with a history of or current drug allergy 3) Those currently having respiratory disease, heart disease, gastrointestinal disease, renal disease, or hepatic disease 4) Those with a history of or current psychiatric disease 5) Those currently having clinically significant orthostatic hypotension 6) Those who have had a bacterial, viral, fungal, or parasitic infection within 28 days prior to signing the informed consent

Related Information

Contact

Public contact
Name Clinical trial information contact
Address 1-9-2, Otemachi , Chiyoda-ku, Tokyo Tokyo Japan 100-0004
Telephone +81-3-5205-7200
E-mail clinical.info.jp@kyowakirin.com
Affiliation Kyowa Kirin Co., Ltd.
Scientific contact
Name Michio Yagi
Address 4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Osaka Osaka Japan 532-0003
Telephone +81-6-6395-9000
E-mail clinical.info.jp@kyowakirin.com
Affiliation Medical Corporation Heishinkai OPHAC Hospital