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OpenTrials
Completed

NCT Number: NCT02970019

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

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SPARC Site 03, Long Beach, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

K0706

Drug

Once a day administration after fast

Placebo

Drug

Once a day administration after fast

Primary outcomes

  1. Adverse events

    Time frame: 4 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 21, 2016
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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