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Japanese

Dec. 24, 2020

May. 28, 2022

jRCT2051200104

A Phase 1 Study of KK6483 in Healthy Male Volunteers

A Phase 1 Study of KK6483 in Healthy Male Volunteers

Yagi Michio

Medical Corporation Heishinkai OPHAC Hospital

4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Osaka

+81-6-6395-9000

clinical.info.jp@kyowakirin.com

Clinical trial information contact

Kyowa Kirin Co., Ltd.

1-9-2, Otemachi , Chiyoda-ku, Tokyo

+81-3-5205-7200

clinical.info.jp@kyowakirin.com

Complete

Dec. 24, 2020

Jan. 06, 2021
40

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) 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

1) 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

20age old over
45age old not

Male

Parkinson's disease

A single oral administration of the investigational product, KK6483C in combination with the existing levodopa (LD)/carbidopa (CD)/entacapone (ET)

Plasma drug concentration
Pharmacokinetic parameters

Kyowa Kirin Co., Ltd.
Medical Corporation Heishinkai OPHAC Hospital IRB
4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Osaka

+81-6-6395-9000

sumiko.kawamoto@heishinkai.com
Approval

Dec. 11, 2020

No

none

History of Changes

No Publication date
4 May. 28, 2022 (this page) Changes
3 May. 19, 2022 Detail Changes
2 June. 09, 2021 Detail Changes
1 Dec. 24, 2020 Detail