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
2 other identifiers
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 2, 2009
CompletedFirst Posted
Study publicly available on registry
April 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedAugust 21, 2009
August 1, 2009
4 months
April 2, 2009
August 20, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To investigate the safety and tolerability of Cogane™ oral solution
Throughout 28 day dosing period
Secondary Outcomes (1)
To investigate the pharmacokinetic profile of Cogane™ and its metabolites
Throughout 28 day dosing period
Study Arms (4)
Cohort A
EXPERIMENTALCohort B
EXPERIMENTALCohort C
EXPERIMENTALCohort D (Optional)
EXPERIMENTALInterventions
Orally active neurotrophic factor inducer
Eligibility Criteria
You may qualify if:
- Male \& Female healthy volunteers aged between 40 and 80 years at the time of informed consent
- Females of non-childbearing potential
- General Good Health
You may not qualify if:
- 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
- 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
- Diagnosis of dementia
- Parkinson's disease of a known genetic cause
- History of surgical intervention for Parkinson's disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Phytopharmlead
Study Sites (1)
LCG Bioscience
Bourn, Cambridgeshire, CB23 2TN, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Investigator
Cambridge, UK
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 2, 2009
First Posted
April 3, 2009
Study Start
April 1, 2009
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
August 21, 2009
Record last verified: 2009-08