Effect of Food on Opicapone Bioavailability and Pharmacodynamics in Healthy Subjects
Abstract
The purpose of this study is to investigate the effect of food on the catechol-O-Methyltransferase (COMT) activity after repeated doses of opicapone (OPC, development code BIA 9-1067) in healthy subjects and to characterize the effects of food on the pharmacokinetics (PK) and tolerability of OPC after repeated doses.
Conditions: Parkinson Disease.
Primary outcome: Maximum observed effect on COMT activity (Emax) - Day 9 (fasted state); Time to occurrence of Emax (tEmax) - Day 9 (fasted state); Area under the effect-time curve (AUEC) - Day 9 (fasted state); Maximum observed effect on COMT activity (Emax) - Day 10 (fed state); Time to occurrence of Emax (tEmax) - Day 10 (fed state); Area under the effect-time curve (AUEC) - Day 10 (fed state).
Enrollment: 28 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 28 participants or records.
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