Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients - Full Text View

Sponsored by:	Phytopharm
Information provided by:	Phytopharm
ClinicalTrials.gov Identifier:	NCT00875316

Purpose

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.

Condition	Intervention	Phase
Parkinson's Disease	Drug: Cogane™ (PYM50028)	Phase I

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety Study
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

Further study details as provided by Phytopharm:

Primary Outcome Measures:

To investigate the safety and tolerability of Cogane™ oral solution [ Time Frame: Throughout 28 day dosing period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To investigate the pharmacokinetic profile of Cogane™ and its metabolites [ Time Frame: Throughout 28 day dosing period ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	April 2009
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort A: Experimental	Drug: Cogane™ (PYM50028) Orally active neurotrophic factor inducer
Cohort B: Experimental	Drug: Cogane™ (PYM50028) Orally active neurotrophic factor inducer
Cohort C: Experimental	Drug: Cogane™ (PYM50028) Orally active neurotrophic factor inducer
Cohort D (Optional): Experimental	Drug: Cogane™ (PYM50028) Orally active neurotrophic factor inducer

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875316

Contacts

Contact: Joanna M Locker, Mrs.	01480 437697 ext 962	jlocker@phytopharm.com
Contact: Darren J Kember, Mr.	01480 437697 ext 964	dkember@phytopharm.com

Locations

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

Sponsors and Collaborators

Phytopharm

Investigators

Principal Investigator:

Investigator

Cambridge, UK

More Information

No publications provided

Responsible Party:	Phytopharm plc ( Mrs. Joanna Locker )
Study ID Numbers:	P58/07CL/ST/08/01, LCG 2237/08
Study First Received:	April 2, 2009
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00875316 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Phytopharm:

Parkinson's disease
Phase I

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases

Healthy
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on May 07, 2009