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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Cogane™ (PYM50028)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Phase I