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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
Sun Pharma Advanced Research Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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
  2. 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
  3. Male or female aged 18 to 65 years (both inclusive)
  4. Diagnosed with Parkinson's disease

Exclusion Criteria:

  1. Clinical diagnosis of genetic form of Parkinson's disease, or drug-induced parkinsonism
  2. Diagnosis of Parkinson's disease Dementia (probable, possible)
  3. Presence of severe dyskinesias
  4. 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

First Posted
November 18, 2016
Last Updated
March 29, 2020
Sponsor
Sun Pharma Advanced Research Company Limited
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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

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Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease

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