PK Study of Modified Release and Divided Dose Tolcapone Formulations
Research type
Research Study
Full title
A Phase 1, Single-Part, 6-Period, Sequential, Non-Randomised, Open-Label Study Designed to Evaluate the Pharmacokinetic Profile of Tolcapone Following Administration of Modified Release Prototype Formulations and an Experimental Divided Dose Regimen in Healthy Subjects
IRAS ID
233212
Contact name
Litza McKenzie
Contact email
Sponsor organisation
Corino Therapeutics Inc.
Eudract number
2017-003070-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 15 days
Research summary
The Sponsor is evaluating longer lasting formulations containing the study drug, tolcapone, for the potential treatment of Transthyretin Amyloidosis (ATTR). Tolcapone is currently used to treat Parkinson's disease in combination with other drugs, it works by slowing down the break down of the other drugs. ATTR causes the build-up of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues. These protein build-ups cause dysfunction in a number of organs, including the nervous system, kidneys, heart, eyes and digestive system.
The study will try to identify the pharmacokinetics (how the study drug moves through the body), safety and tolerability of tolcapone modified release prototype formulations and divided dose regimen.
The study will consist of 6 periods involving up to 15 healthy male and female subjects. In Period 1, up to 15 subjects will receive a dose of a currently marketed immediate release tolcapone tablet to test their tolerability.
In periods 2 to 6, 12 healthy subjects who showed tolerability to tolcapone in period 1 will receive once daily or twice daily oral doses of the tolcapone modified release prototype formulations. During period 3 the subjects will receive an experimental divided dose regimen and during period 5 or 6 the effect of food on the pharmacokinetics may be assessed by dosing after a high fat breakfast.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0226
Date of REC Opinion
29 May 2018
REC opinion
Further Information Favourable Opinion