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

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Cogane™ (PYM50028)

• Registration Number: NCT00875316
• Lead Sponsor: Phytopharm

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Status Verified: 2009-08
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Last Update Submitted: 2009-08-20
• Last Update Posted: 2009-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort A	Cogane™ (PYM50028)	-
Cohort B	Cogane™ (PYM50028)	-
Cohort C	Cogane™ (PYM50028)	-
Cohort D (Optional)	Cogane™ (PYM50028)	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

LCG Bioscience; 🇬🇧 Bourn, Cambridgeshire, United Kingdom