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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00875316

Enrollment

Registered

2009-04-03

Start date

2009-04-30

Completion date

2009-08-31

Last updated

2009-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, Phase I

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.

Interventions

DRUGCogane™ (PYM50028)

Orally active neurotrophic factor inducer

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026