Safety, Tolerability and Pharmacokinetics of Miricorilant (QSC203474)
Research type
Research Study
Full title
A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of Miricorilant Tablet Formulations Following Single and Multiple Oral Doses in Healthy Subjects
IRAS ID
275245
Contact name
Hazel Hunt
Contact email
Sponsor organisation
Corcept Therapeutics
Eudract number
2019-004655-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 11 days
Research summary
The Sponsor is developing the test medicine, miricorilant, for the potential treatment of non-alcoholic steatohepatitis (NASH) and antipsychotic-induced weight gain (AIWG). NASH is a serious form of non-alcoholic fatty liver disease, where the liver becomes inflamed. AIWG is where patients taking antipsychotics have a tendency to gain weight, which may also increase insulin resistance.
The study will try to provide additional safety and tolerability information of the test medicine following single and multiple oral doses that result in higher exposures than given in previous studies. It will also try to identify the level of test medicine in the blood (pharmacokinetics – PK), when given orally.
The study will consist of 3 cohorts each involving up to 12 healthy male and female volunteers of non-childbearing potential. In Cohort 1 volunteers will receive a single dose of test medicine. In Cohorts 2 and 3 volunteers will receive one single dose of test medicine or matching placebo, and then return to receive multiple doses of the test medicine or placebo, either once daily or twice daily for 14 days.
In Cohort 1, volunteers will remain on site until 72-hours post dose (Day 4), they will return on approximately Day 7 for a follow-up visit for safety monitoring and PK blood sampling.
In Cohorts 2 and 3, for their first study visit subjects will remain on site until 72-hours post dose. There will then be a washout period of a minimum of 7 days, following this they will return for the second study visit. They will then remain on site until 72-hours post final dose (Day 17). They will return for a follow-up visit on approximately Day 21 for safety monitoring and PK blood sampling.REC name
HSC REC A
REC reference
20/NI/0024
Date of REC Opinion
5 Mar 2020
REC opinion
Further Information Favourable Opinion