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

Phytopharm

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: Cogane™ (PYM50028)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00875316

P58/07CL/ST/08/01

LCG 2237/08

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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36 participants in 4 patient groups

Cohort A

Experimental group

Treatment:

Drug: Cogane™ (PYM50028)

Cohort B

Experimental group

Treatment:

Drug: Cogane™ (PYM50028)

Cohort C

Experimental group

Treatment:

Drug: Cogane™ (PYM50028)

Cohort D (Optional)

Experimental group

Treatment:

Drug: Cogane™ (PYM50028)