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Completed

NCT Number: NCT00875316

Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients

Phytopharm plc is developing Cogane™ which is a new medicine for the treatment of Parkinson's disease (PD). The purpose of the study is to find out if Cogane is safe and well tolerated in both healthy volunteers and Parkinson's disease patients and to determine if there is a difference in the way that the body deals with Cogane (pharmacokinetics) between these two groups.

It is expected that the study will prove that Cogane™ is safe and well tolerated and will provide us with a pharmacokinetic profile for both subject groups.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

LCG Bioscience

Bourn, Cambridgeshire, CB23 2TN, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria (Healthy Volunteers):

  • Male & Female healthy volunteers aged between 40 and 80 years at the time of informed consent
  • Females of non-childbearing potential
  • General Good Health

Key Exclusion Criteria (Healthy Volunteers):

  • No clinically significant and relevant medical history
  • Smoked within the 3 months prior to screening
  • Use of prescription or non-prescription systemic or topical medication (including herbal remedies) within 14 days of the first dose administration

Key Inclusion Criteria (Parkinson's disease patients):

  • Male & Female Parkinson's disease patients aged between 40 and 80 years at the time of informed consent
  • Must have a diagnosis of idiopathic Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria
  • Subjects who are taking Parkinson's disease treatments should be on a stable regimen for at least 4 weeks prior to screening

Key Exclusion Criteria (Parkinson's disease patients):

  • Diagnosis of dementia
  • Parkinson's disease of a known genetic cause
  • History of surgical intervention for Parkinson's disease

Treatment and study plan

Cogane™ (PYM50028)

Drug

Orally active neurotrophic factor inducer

Primary outcomes

  1. To investigate the safety and tolerability of Cogane™ oral solution

    Time frame: Throughout 28 day dosing period

Secondary outcomes

  1. To investigate the pharmacokinetic profile of Cogane™ and its metabolites

    Time frame: Throughout 28 day dosing period

Sponsors and collaborators

Lead sponsor

Phytopharm

Industry

Registry information

Official study title

A Randomised, Double-blind, Multiple Dose-ascending, Placebo-controlled Study in Healthy Volunteers and Parkinson's Disease Patients to Assess the Safety, Tolerability and PK of Daily Oral Administration of Cogane™ Over One Month

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 3, 2009
Registry last updated
Aug 21, 2009

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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