A Phase 1 Study of KK6483 in Healthy Male Volunteers
Phase 1
- Conditions
- Parkinson's disease
- Registration Number
- JPRN-jRCT2051200104
- Lead Sponsor
- Yagi Michio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 40
Inclusion 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
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma drug concentration<br>Pharmacokinetic parameters
- Secondary Outcome Measures
Name Time Method