A phase 1, randomized, double blind, placebo controlled, multiple ascending dose, safety and pharmacodynamic study of MDV1634 in patients with Parkinson*s disease.
Completed
- Conditions
- paralysis agitansParkinson's disease10028037
- Registration Number
- NL-OMON42429
- Lead Sponsor
- Medivation, Inc. and its Subsidiaries
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Male and female volunteers
Parkinson disease
30-75 years of age
BMI 18-35 kg/m2, inclusive
Exclusion Criteria
CYP2D6 genotype indicating poor or intermediate metabolizer status; Montreal Cognitive Assessment score < 24; hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of MDV1634 in patients with Parkinson*s<br /><br>disease.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the pharmacokinetics of MDV1634 in patients with Parkinson*s disease<br /><br>To evaluate the effect of MDV1634 on biomarkers of Parkinson*s disease.<br /><br>To evaluate the relationship between MDV1634 pharmacokinetics and biomarkers<br /><br>and/or safety outcomes in patients with Parkinson*s disease.</p><br>