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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- To investigate the safety and tolerability of Cogane™ oral solution
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort A
Intervention: Cogane™ (PYM50028) (Drug)
Cohort B
Intervention: Cogane™ (PYM50028) (Drug)
Cohort C
Intervention: Cogane™ (PYM50028) (Drug)
Cohort D (Optional)
Intervention: Cogane™ (PYM50028) (Drug)
Outcomes
Primary Outcomes
To investigate the safety and tolerability of Cogane™ oral solution
Time Frame: Throughout 28 day dosing period
Secondary Outcomes
- To investigate the pharmacokinetic profile of Cogane™ and its metabolites(Throughout 28 day dosing period)