A study to investigate CORT-125134 in Healthy Volunteers (QBR116598)
Research type
Research Study
Full title
A Phase I Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Measure the Safety, Tolerability, Pharmacokinetics and Pharmacological Effects of Orally Administered CORT125134 in Healthy Male and Female Subjects
IRAS ID
160777
Contact name
Hazel Hunt
Contact email
Sponsor organisation
Corcept Therapeutics
Eudract number
2014-001951-21
Research summary
The Sponsor is developing the study drug, CORT-125134, for the potential treatment of Cushing's Syndrome (a condition which is caused by excessive amounts of a hormone called cortisol in the body).
The study will try to identify how the body absorbs and process the study drug as well as assess the safety and tolerability of the drug.
The study will consist of 2 parts involving up to 124 healthy male and female subjects. In Part 1, cohorts 1-6, each cohort of 10 subjects will receive a planned dose of between 5 and 400 mg study drug or placebo. In Cohort 7 subjects will receive the study drug with food. In Cohorts 8 and 9 subjects will receive the study drug with another medicine to investigate the effects of the drug.
In Part 2, each cohort of 12 subjects will receive multiple doses of the study drug (or placebo) for 14 days decided upon based on the results of Part 1. In cohort 12 subjects will receive the study drug with another medicine to investigate the effects of the drug
REC name
Wales REC 2
REC reference
14/WA/1097
Date of REC Opinion
28 Aug 2014
REC opinion
Further Information Favourable Opinion