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

March 29, 2020 updated by: Sun Pharma Advanced Research Company Limited

A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • SPARC Site 03
      • Panorama City, California, United States, 91402
        • SPARC Site 05
    • Florida
      • DeLand, Florida, United States, 32720
        • SPARC Site 01
      • Orlando, Florida, United States, 32806
        • SPARC Site 02
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • SPARC Site 04

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak plasma concentration
Time Frame: 4 weeks
4 weeks
Area under the plasma concentration versus time curve
Time Frame: 4 weeks
4 weeks
Time of observed peak plasma concentration
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharma Advanced Research Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2017

Primary Completion (Actual)

May 28, 2019

Study Completion (Actual)

May 28, 2019

Study Registration Dates

First Submitted

November 18, 2016

First Submitted That Met QC Criteria

November 18, 2016

First Posted (Estimate)

November 21, 2016

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 29, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLR_16_27

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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