Study of CP-012 delayed release tablets in patients with Parkinson’s.
Research type
Research Study
Full title
A pharmacoscintigraphic single-centre, open-label, randomised, 3-way cross-over study in patients with Parkinson’s to evaluate a novel delayed release, dual pulse carbidopa and levodopa tablet, CP-012.
IRAS ID
1010244
Contact name
Kenneth Christensen
Contact email
Sponsor organisation
Contera Pharma
ISRCTN Number
ISRCTN14216648
Research summary
This is a single centre, open label, overnight study in up to 15 patients aged between 40-80 years old.\nThis study is designed to investigate the absorption of two delayed release radiolabelled carbidopa and levodopa tablets and correlate with scintigraphic time and site of release. Pharmacokinetics performance of the time delayed products will also be compared with a commercially available marketed product.\nThe following treatments will be dosed as part of this study:\nTreatment A: One radiolabelled delayed release tablet (CP-012A) containing 25mg carbidopa and 100mg levodopa designed to release carbidopa at 4 hours post dose with second pulse of levodopa 0.5-1 hours later AND one immediate-release 25mg carbidopa and 100mg levodopa (SINEMET® Plus 25 mg/100 mg Tablet)\nTreatment B: One radiolabelled delayed release tablet (CP-012B) containing 25mg carbidopa and 100mg levodopa designed to release carbidopa at 6 hours post dose with a second pulse of levodopa 0.5-1 hours later AND one immediate-release 25mg carbidopa and 100mg levodopa (SINEMET® Plus 25 mg/100 mg Tablets)\nTreatment C (reference therapy): One non-radiolabelled tablet of immediate-release 25mg carbidopa and 100mg levodopa (SINEMET® Plus 25 mg/100 mg Tablets)\n\nIn this study we will use scintigraphic imaging to confirm the site of release of treatments A and B in the gastrointestinal tract. To look at this parameter, we will add a small amount of radioactive material to the CP012 tablets of treatment A+B. Blood samples will also be taken at specific timepoints throughout each visit to assess the concentration of carbidopa and levodopa in the blood.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0438
Date of REC Opinion
25 Jul 2024
REC opinion
Favourable Opinion