Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
K0706
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
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
Sites / Locations
- SPARC Site 03
- SPARC Site 05
- SPARC Site 01
- SPARC Site 02
- SPARC Site 04
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
K0706
Placebo
Arm Description
K0706 will be administered once a day
Placebo will be administered once a day
Outcomes
Primary Outcome Measures
Adverse events
Secondary Outcome Measures
Peak plasma concentration
Area under the plasma concentration versus time curve
Time of observed peak plasma concentration
Full Information
NCT ID
NCT02970019
First Posted
November 18, 2016
Last Updated
March 29, 2020
Sponsor
Sun Pharma Advanced Research Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT02970019
Brief Title
Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease
Official Title
A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
May 28, 2019 (Actual)
Study Completion Date
May 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharma Advanced Research Company Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
K0706
Arm Type
Experimental
Arm Description
K0706 will be administered once a day
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo will be administered once a day
Intervention Type
Drug
Intervention Name(s)
K0706
Intervention Description
Once a day administration after fast
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once a day administration after fast
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Peak plasma concentration
Time Frame
4 weeks
Title
Area under the plasma concentration versus time curve
Time Frame
4 weeks
Title
Time of observed peak plasma concentration
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
SPARC Site 03
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
SPARC Site 05
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
SPARC Site 01
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
SPARC Site 02
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
SPARC Site 04
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease
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