Pharmacoscintigraphic evaluation of delayed release, dual pulse carbidopa and levodopa tablet CP-012
Research type
Research Study
Full title
An exploratory pharmacoscintigraphic single centre, open-label, crossover study in healthy volunteers to evaluate a novel delayed release, dual pulse carbidopa and levodopa tablet CP-012
IRAS ID
1007120
Contact name
Kenneth Christensen
Contact email
Sponsor organisation
Contera Pharma
Eudract number
2022-004170-28
ISRCTN Number
ISRCTN79577836
Research summary
This is a single centre, three arm, open label cross over study in up to 15 healthy male volunteers aged between 18-60 years old. This study is designed to investigate the absorption of two delayed release dual pulse radiolabelled prototype carbidopa and levodopa tablets and correlate with scintigraphic time and site of release. PK 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 dual pulse prototype tablet (CP-012) is designed to release 25mg carbidopa after a 4 hour delay with a second pulse of levodopa 0.5-1 hours later. \nTreatment B dual pulse prototype tablet (CP-012) is designed to release 25mg carbidopa after a 6 hour delay with a second pulse of levodopa 0.5-1 hours later.\nSubjects will also receive one marketed comparator tablet (treatment C) also containing 25mg carbidopa and 100mg levodopa.\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 materials to these tablets. Blood samples will also be taken at specific timepoints throughout each visit to asses the absorption of carbidopa and levodopa in the blood.
REC name
London - London Bridge Research Ethics Committee
REC reference
23/LO/0037
Date of REC Opinion
22 Aug 2023
REC opinion
Further Information Favourable Opinion