Phase 1 Safety, Tolerability, PK and Pharmacological study QCL117938
Research type
Research Study
Full title
A Phase I Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacological Effects of Orally Administered CORT118335 in Healthy Subjects
IRAS ID
225086
Contact name
Hazel Hunt
Contact email
Sponsor organisation
Corcept Therapeutics
Eudract number
2017-000869-73
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 12 days
Research summary
The Sponsor is developing the study drug, CORT118335, for the potential treatment of non-alcoholic fatty liver disease. Non-alcoholic fatty liver disease (NAFLD) is a term used for 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. Early stage NAFLD (when there are small amounts of fat in the liver) does not usually cause any harm but can lead to liver damage.
This is a 3 part study involving healthy male and female subjects. The study will look at the safety of the study drug and how the body tolerates it, as well as how it is taken up by the body.
Part 1 will evaluate the safety, tolerability and pharmacokinetics (level of study drug in the blood) of single doses of CORT118335. Subjects will be enrolled into 1 of up to 7 cohorts, each containing 8 subjects.
Part 2 will investigate the effect of food, and will examine the pharmacodynamics effects (how the drug affects the body). Subjects will be enrolled into 1 of 2 cohorts (A and B), each containing 12 subjects.
Part 3 will evaluate the safety, tolerability and pharmacokinetics (level of study drug in the blood) of multiple doses of CORT118335. Subjects in Part 3 will be enrolled into 1 of 4 cohorts (A-D), each containing 12 subjects. Part 3 includes an optional cohort (D), which may be used to look at the effects of the study drug when given as multiple doses with another drug.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0227
Date of REC Opinion
22 May 2017
REC opinion
Favourable Opinion