PK Study of Zavacorilant in Healthy Volunteers (QSC301567)
Research type
Research Study
Full title
A Phase I Pharmacokinetic Assessment of Zavacorilant Softgel Capsule Formulation, Including Dose Proportionality and Food Effect in Healthy Subjects
IRAS ID
1009209
Contact name
Hazel Hunt
Contact email
Sponsor organisation
Corcept Therapeutics Incorporated
Research summary
The Sponsor is developing the test medicine zavacorilant (also know as CORT125329), for the potential treatment of neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS - also known as Motor Neurone Disease), Huntington’s disease (HD), and Alzheimer’s disease (AD). Neurodegenerative diseases occur when nerve cells in the brain, spinal cord or body lose function over time and ultimately die. These diseases affect millions of people worldwide. It’s common for patients to have a higher level of cortisol (a steroid hormone produced by the adrenal gland), which is known to affect the nervous system. The test medicine reduces the effects of cortisol and has shown beneficial effects in a mouse model of ALS.
In this study, we’ll compare side effects and blood levels in healthy volunteers after the test medicine is given with and without food (relative bioavailability) and at increasing dose levels.
This study will take place at 1 site in Nottingham.
We plan to enrol 18 healthy men and women who are unable to have a baby, aged 18 to 60 years.
Six volunteers will receive 2 single doses of test medicine as capsules, one fasted and one fed. They’ll stay in the clinic for up to 4 nights each dose, and take up to 7 weeks to finish the study.
Twelve volunteers will receive a single doses of test medicine as capsules, either fasted or fed. They’ll stay in the clinic for up to 4 nights, and take up to 6 weeks to finish the study.
We’ll collect blood and urine samples to complete safety tests and measure the amount of test medicine and one of it's breakdown products (in blood).REC name
HSC REC B
REC reference
24/NI/0002
Date of REC Opinion
8 Mar 2024
REC opinion
Further Information Favourable Opinion