Drug-Drug Interaction Study of Miricorilant (QSC300704)
Research type
Research Study
Full title
An Open-Label, Drug-Drug Interaction Study Designed to Evaluate the Potential Effect of Miricorilant on Cytochrome P450 2C8, 2C9, 3A4, Uridine-diphospho-glucuronosyltransferase 1A1 Enzyme Activity, and Breast Cancer Resistance Protein Activity Using Probe Substrates in Healthy Male and Female Subjects
IRAS ID
1007538
Contact name
Joseph Custodio
Contact email
Sponsor organisation
Corcept Therapeutics Incorporated
Research summary
The Sponsor is developing the test medicine, miricorilant, for the potential treatment of Antipsychotic-Induced Weight Gain (AIWG) and Non-Alcoholic Steatohepatitis (NASH). AIWG is the condition in which patients taking antipsychotic medications tend to gain weight. In addition to weight gain, antipsychotic medications increase insulin resistance thereby increasing the risk of patients developing cardiovascular disease (diseases that affect the heart and blood vessels). NASH develops from non-alcoholic fatty liver disease (NAFLD), which is a range of conditions caused by a build-up of fat in the liver and is usually seen in overweight or obese people. A healthy liver should contain little or no fat.
This one-part, healthy subject drug-drug interaction study aims to assess the pharmacokinetics (PK, what the body does to the drug) of five approved marketed medicines when given with and without the test medicine, miricorilant in fed conditions (with food). This study will take place at one non-NHS site and will consist of a single study period involving up to 30 healthy male or female (of non-childbearing potential) subjects, aged between 18 and 60. Subjects will be admitted in the evening of Day -1. Subjects will receive an oral dose of Repaglinide (0.5 mg tablet); Tolbutamide (500 mg tablet); Midazolam (2.5 mg oral solution); Dolutegravir (50 mg tablet); Rosuvastatin (10 mg tablet) on two occasions (on the mornings of Day 1 and Day 10). On the mornings of Day 4 to Day 12, subjects will receive 400 mg of miricorilant, as 8 x 50 mg tablets. Subjects will be discharged on Day 13 and will receive a follow-up phone call, 4 to 11 days post-final test medicine dose.
Subject’s blood and urine will be taken throughout the study for analysis of the test medicine and marketed medicines, as well as for their safety. Subjects are expected to be involved in this study for approximately 7 weeks from screening to the follow-up call.
REC name
London - Hampstead Research Ethics Committee
REC reference
23/LO/0227
Date of REC Opinion
4 Sep 2023
REC opinion
Further Information Favourable Opinion