PK, PD and Safety of Multiple Doses of V1512 Tablets in PD Patients Compared to Standard Levodopa/Carbidopa Oral Tablets

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine if the pharmacokinetic profile of V1512 is similar or better than existing medications for the treatment of Parkinson's Disease

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vernalis (R&D) Ltd
• Collaborators: Cita NeuroPharmaceuticals; INC Research; Syneos Health
• Treatments: Entacapone

Criteria

Inclusion Criteria:

1. Male or female, >30 years of age of any race;

2. A Body Mass Index between 18.5 and 29.9 kg/m2 (inclusive);

3. Clinical diagnosis according to the Brain Bank diagnostic criteria of idiopathic Parkinson's Disease (2 of 3 cardinal symptoms - bradykinesia, rigidity, tremor -must be present, with a positive response to L-dopa);

4. Presence of fluctuations in motor performance with >2 hours inclusive of daytime OFF episodes (not applicable for cohort 1 patients);

5. At least 1 hour delay to ON time with afternoon doses;

6. Discontinued use of COMT inhibitors (cathecol-o-methyl transferase) for at least 2 weeks prior to study entry (not applicable for cohort 3 patients);

7. Stable doses of dopamine agonists or selegiline for at least 2 weeks before entry into the study;

8. Stable comorbidity for 4 weeks;

9. Female patients must be of non-childbearing potential (post-menopausal or physically incapable of childbearing);

10. Willing and able to give informed consent according to national legal requirements prior to initiation of any study-related procedures

Exclusion Criteria:

1. Clinically relevant abnormal vital sign values or safety laboratory data.

2. Patients who smoke and are unable to refrain from smoking during the in-clinic period

3. Diagnosis of atypical parkinsonism;

4. A history and/or the presence of gastro-intestinal disorders (or surgery) that could interfere with absorption of the test medication;

5. A history of intolerance or clinically relevant allergy to L-dopa and/or carbidopa taken in any formulation or combination;

6. A history of intolerance or clinically relevant allergy to entacapone or any ingredients of Comtan (cohort 3 patients only)

7. Any other condition which, in the opinion of the Investigator, would interfere with optimal participation in the study e.g. inability to complete patient diary;

8. Participation in any clinical study or receiving treatment with another investigational drug within 30 days or 5 half lives (whichever is longer) before the screening visit;

9. Blood donation within 3 months before study participation;

10. History of neuroleptic malignant syndrome (NMS) or NMS-like syndromes, or non-traumatic rhabdomyolysis;

11. Patients taking non-selective MAO inhibitors;

12. Patients with a history of, or clinical indication of, narrow angle glaucoma;

13. Patients with a history of, or clinical indication of, malignant melanoma;

14. Patients with a history of, or clinical indication of, depression or psychosis;

15. Patients taking iron containing medications (ferrous sulphate, ferrous gluconate)