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

August 20, 2009 updated by: Phytopharm

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

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 Kingdom
    • Cambridgeshire
      • Bourn, Cambridgeshire, United Kingdom, CB23 2TN
        • LCG Bioscience

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

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort B
Drug: Cogane™ (PYM50028)
Orally active neurotrophic factor inducer
Experimental: Cohort A
Drug: Cogane™ (PYM50028)
Orally active neurotrophic factor inducer
Experimental: Cohort C
Drug: Cogane™ (PYM50028)
Orally active neurotrophic factor inducer
Experimental: Cohort D (Optional)
Drug: Cogane™ (PYM50028)
Orally active neurotrophic factor inducer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To investigate the safety and tolerability of Cogane™ oral solution
Time Frame: Throughout 28 day dosing period
Throughout 28 day dosing period

Secondary Outcome Measures

Outcome Measure
Time Frame
To investigate the pharmacokinetic profile of Cogane™ and its metabolites
Time Frame: Throughout 28 day dosing period
Throughout 28 day dosing period

Collaborators and Investigators

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

Sponsor

Phytopharm

Investigators

  • Principal Investigator: Investigator, Cambridge, UK

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

April 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

April 2, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (Estimate)

April 3, 2009

Study Record Updates

Last Update Posted (Estimate)

August 21, 2009

Last Update Submitted That Met QC Criteria

August 20, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P58/07CL/ST/08/01
  • LCG 2237/08

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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