A bioequivalence and food effect study of mavodelpar in healthy volunteers
Research type
Research Study
Full title
A Phase 1, Randomized, Open-Label, Single-Dose, Three-Period Crossover Bioequivalence And Food Effect Study With Orally Administered Mavodelpar Tablet And Capsule Formulations In Healthy Subjects.
IRAS ID
1006936
Contact name
Gabrielle Brill
Contact email
Sponsor organisation
Reneo Pharma Ltd.
Eudract number
2022-003704-32
ISRCTN Number
ISRCTN85791974
Research summary
The purpose of this study is to investigate mavodelpar. The main objectives of the study are as follows:\n\n- To evaluate and compare the bioequivalence (assessment of whether the two formulations can be considered the same in terms of concentration levels in the blood at various timepoints) of mavodelpar when it is administered as an oral tablet versus an oral capsule.\n\n- To investigate the effect of food on the concentration of mavodelpar in the blood following administration of mavodelpar in both a fasted state (without food) and fed state (following a high-fat, high-calorie meal).\n\n- To investigate the concentration of mavodelpar in the blood, how this changes over a period of time and to measure if and how this concentration differs when mavodelpar is administered as an oral tablet versus an oral capsule.\n\n- To determine the safety and tolerability (degree to which side effects of the study drug can be tolerated) of mavodelpar when it is administered as a single dose in different forms i.e., as an oral tablet versus an oral capsule and following administration in a fasted state (without food) and fed state (following a high-fat, high-calorie meal).\n\nThe study will consist of up to 32 participants with each participant required to complete all three treatment periods. Across the three treatment periods, each participant will receive:\n- a single dose of mavodelpar (100 milligrams (mg)) in the form of an oral capsule following a high-fat, high calorie meal, \n- a single dose of 100 mg mavodelpar in the form of an oral tablet following a high-fat, high-calorie meal and \n- a single dose of 100 mg mavodelpar in either the form of capsule or tablet in a fasted state. \n\nBlood samples will be taken during the study in order to measure the concentration of mavodelpar in the blood and we will evaluate the results from each treatment period to determine if there are any significant differences between the two forms and taking the drug with or without food.
REC name
Wales REC 2
REC reference
23/WA/0128
Date of REC Opinion
30 Aug 2023
REC opinion
Further Information Favourable Opinion