A Phase 1 Study of KK6483 in Healthy Male Volunteers

JRCT ID: jRCT2051200104

Registered date:24/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 06/01/2021
• Target sample size: 40
• Study type: Interventional
• 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 Outcome

Plasma drug concentration
Pharmacokinetic parameters

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 45age old
• Gender: Male

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Yagi Michio