Back to resultsSafety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Cogane™ (PYM50028)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Phase I
Eligibility Criteria
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
Sites / Locations
- LCG Bioscience
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort A
Cohort B
Cohort C
Cohort D (Optional)
Arm Description
Outcomes
Primary Outcome Measures
To investigate the safety and tolerability of Cogane™ oral solution
Secondary Outcome Measures
To investigate the pharmacokinetic profile of Cogane™ and its metabolites
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00875316
Brief Title
Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Phytopharm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Phase I
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort A
Arm Type
Experimental
Arm Title
Cohort B
Arm Type
Experimental
Arm Title
Cohort C
Arm Type
Experimental
Arm Title
Cohort D (Optional)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cogane™ (PYM50028)
Intervention Description
Orally active neurotrophic factor inducer
Primary Outcome Measure Information:
Title
To investigate the safety and tolerability of Cogane™ oral solution
Time Frame
Throughout 28 day dosing period
Secondary Outcome Measure Information:
Title
To investigate the pharmacokinetic profile of Cogane™ and its metabolites
Time Frame
Throughout 28 day dosing period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Investigator
Organizational Affiliation
Cambridge, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
LCG Bioscience
City
Bourn
State/Province
Cambridgeshire
ZIP/Postal Code
CB23 2TN
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients
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