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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02970019
Recruitment Status : Active, not recruiting
First Posted : November 21, 2016
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Brief Summary:
This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: K0706 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.
Actual Study Start Date : March 30, 2017
Actual Primary Completion Date : May 28, 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: K0706
K0706 will be administered once a day
Drug: K0706
Once a day administration after fast

Experimental: Placebo
Placebo will be administered once a day
Drug: Placebo
Once a day administration after fast




Primary Outcome Measures :
  1. Adverse events [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Peak plasma concentration [ Time Frame: 4 weeks ]
  2. Area under the plasma concentration versus time curve [ Time Frame: 4 weeks ]
  3. Time of observed peak plasma concentration [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970019


Locations
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United States, California
SPARC Site 03
Long Beach, California, United States, 90806
SPARC Site 05
Panorama City, California, United States, 91402
United States, Florida
SPARC Site 01
DeLand, Florida, United States, 32720
SPARC Site 02
Orlando, Florida, United States, 32806
United States, North Carolina
SPARC Site 04
Raleigh, North Carolina, United States, 27612
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited

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Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT02970019     History of Changes
Other Study ID Numbers: CLR_16_27
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases