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

This study has been completed.
Sponsor:
Information provided by:
Phytopharm
ClinicalTrials.gov Identifier:
NCT00875316
First received: April 2, 2009
Last updated: August 20, 2009
Last verified: August 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A Drug: Cogane™ (PYM50028)
Orally active neurotrophic factor inducer
Experimental: Cohort B Drug: Cogane™ (PYM50028)
Orally active neurotrophic factor inducer
Experimental: Cohort C Drug: Cogane™ (PYM50028)
Orally active neurotrophic factor inducer
Experimental: Cohort D (Optional) 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
LCG Bioscience
Bourn, Cambridgeshire, United Kingdom, CB23 2TN
Sponsors and Collaborators
Phytopharm
Investigators
Principal Investigator: Investigator Cambridge, UK
  More Information

No publications provided

Responsible Party: Mrs. Joanna Locker, Phytopharm plc
ClinicalTrials.gov Identifier: NCT00875316     History of Changes
Other Study ID Numbers: P58/07CL/ST/08/01, LCG 2237/08
Study First Received: April 2, 2009
Last Updated: August 20, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Phytopharm:
Parkinson's disease
Phase I

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on October 30, 2014