NCT02970019
Completed
Phase 1
A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.
Overview
- Phase
- Phase 1
- Intervention
- K0706
- Conditions
- Parkinson Disease
- Sponsor
- Sun Pharma Advanced Research Company Limited
- Enrollment
- 60
- Locations
- 5
- Primary Endpoint
- Adverse events
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willing and able to give written, and dated, informed consent (or legally acceptable representative/impartial witness when applicable) and is available for the entire study
- •Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (in the Investigator's opinion), and be accessible for follow-up
- •Male or female aged 18 to 65 years (both inclusive)
- •Diagnosed with Parkinson's disease
Exclusion Criteria
- •Clinical diagnosis of genetic form of Parkinson's disease, or drug-induced parkinsonism
- •Diagnosis of Parkinson's disease Dementia (probable, possible)
- •Presence of severe dyskinesias
- •History of brain surgery for Parkinson's disease
Arms & Interventions
K0706
K0706 will be administered once a day
Intervention: K0706
Placebo
Placebo will be administered once a day
Intervention: Placebo
Outcomes
Primary Outcomes
Adverse events
Time Frame: 4 weeks
Secondary Outcomes
- Time of observed peak plasma concentration(4 weeks)
- Peak plasma concentration(4 weeks)
- Area under the plasma concentration versus time curve(4 weeks)
Study Sites (5)
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