Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Completed
First Posted : November 21, 2016
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Tracking Information
First Submitted Date  ICMJE November 18, 2016
First Posted Date  ICMJE November 21, 2016
Last Update Posted Date March 31, 2020
Actual Study Start Date  ICMJE March 30, 2017
Actual Primary Completion Date May 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
Adverse events [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
Adverse evants [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2018)
  • Peak plasma concentration [ Time Frame: 4 weeks ]
  • Area under the plasma concentration versus time curve [ Time Frame: 4 weeks ]
  • Time of observed peak plasma concentration [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2016)
  • Cmax [ Time Frame: 24 weeks ]
  • AUC [ Time Frame: 24 weeks ]
  • Tmax [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease
Official Title  ICMJE A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.
Brief Summary This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: K0706
    Once a day administration after fast
  • Drug: Placebo
    Once a day administration after fast
Study Arms  ICMJE
  • Experimental: K0706
    K0706 will be administered once a day
    Intervention: Drug: K0706
  • Experimental: Placebo
    Placebo will be administered once a day
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2020)
60
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2016)
360
Actual Study Completion Date  ICMJE May 28, 2019
Actual Primary Completion Date May 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02970019
Other Study ID Numbers  ICMJE CLR_16_27
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sun Pharma Advanced Research Company Limited
Study Sponsor  ICMJE Sun Pharma Advanced Research Company Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Pharma Advanced Research Company Limited
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP