* PK Study of CORT113176 in Healthy Volunteers (QSC207407)
Research type
Research Study
Full title
A Phase 1 Single Dose Study to Evaluate the Pharmacokinetics of CORT113176 Softgel Capsules in Healthy Subjects
IRAS ID
1005009
Contact name
Hazel Hunt
Contact email
Sponsor organisation
Corcept Therapeutics Incorporated
Eudract number
2022-000181-18
ISRCTN Number
ISRCTN52169163
Research summary
Research Summary
The Sponsor is developing the test medicine, CORT113176, for the potential treatment of Amyotrophic Lateral Sclerosis (ALS), a rare disease with insufficient treatment options. It is characterised by progressive degeneration of motor neurons in both the brain and the spinal cord leading to progressive muscle weakness, relentless disability, and death, typically within 3 to 5 years from symptom onset.
This 2-period healthy volunteer study will evaluate the pharmacokinetics (what the body does to the drug) of CORT113176 softgel capsules when administered as single oral doses in healthy subjects, and to assess the effect of food.
This single centre, phase 1 study will take place at Quotient Sciences, Mere Way, Ruddington Fields, Nottingham, NG11 6JS, UK enrolling up to 16 male and female volunteers aged between 18 to 60 years.
After a screening assessment, volunteers will enter the clinical unit on Day -1, and will be dosed with the test medicine on Day 1, either with or without food. Volunteers will be discharged on Day 4. There will then be a minimum of 7 days between doses and volunteers will return to the clinical unit for period 2. Volunteers will be dosed with the same dose of the test medicine as in period 1, in the opposite fed/fasted state.
Blood and urine will be collected from volunteers throughout the study for analysis of the test medicine and for safety assessments.
Volunteers are expected to be involved in this study for approximately 6 weeks from screening to follow up.
Summary of Results
The Sponsor for this study was Corcept Therapeutics, a small pharmaceutical company based in the US. The study was conducted by Quotient Sciences (a clinical research organisation) in Nottingham, UK.
The study took place from 15 Mar 2022 until 09 May 2022 at the Quotient Sciences Clinical Unit in Nottingham, UK.
We would like to take this opportunity to thank all study volunteers.What was this study about?
The purpose of this study was to find out how a single dose of the test medicine, CORT113176, given as softgel capsules, was taken up by the body when given in a fed (with food) and fasted (without food) state. Two groups of volunteers took part in the study, with one group given a lower dose and the other given a higher dose of the test medicine. Each subject took the selected dose twice, once with food and once without food.
The safety and tolerability of the test medicine was also investigated.
This was not the first time this medicine had been given to people.Who took part in this study?
Overall, 16 healthy men and healthy women, who were not able to have children, took part in the study (8 volunteers in each group).
In Group A, the youngest volunteer was 39 years old, and the oldest volunteer was 59 years old.
In Group B, the youngest volunteer was 34 years old, and the oldest volunteer was 60 years old.How was this study done?
Volunteers attended the clinical site for 2 study periods. This was an open-labelled study, meaning volunteers knew which treatment they were receiving. Volunteers were dosed once with food and once without food. The order in which each volunteer was dosed was decided in a randomised manner – half of the volunteers were dosed with food in the first period and without food in the second period, and the remaining volunteers were dosed the other way around.
Volunteers received 1 dose of test medicine as capsules to swallow with water on Day 1 of each period. Volunteers in Group A were given a lower dose of test medicine in each period, and volunteers in Group B were given a higher dose of test medicine in each period.
Volunteers went home on Day 4 in each period, then came back on Day 5 for blood samples.
There was a break of at least 7 days between each period so that the first dose of test medicine was cleared from the body before volunteers were given the next test medicine. After the second (final) period, volunteers came back after around 7 days for further safety checks.
Blood samples were collected from the volunteers for 5 days after they were dosed with the test medicine in both periods, to find out the amount of test medicine in the body over time.
The results of the different dosages of the test medicine taken with and without food were compared with one another at the end of the study, to see how taking the test medicine with and without food affects how much of the test medicine is taken up into the body.
The study staff also collected information about the volunteers’ health throughout the study.What were the results of this study?
For both groups, the highest blood levels of test medicine occurred at about 1½ hours after the test medicine was swallowed without food and 3 hours after the test medicine was swallowed with food.
Volunteers who took the higher dose of the test medicine (Group B) had higher amounts of test medicine in the blood compared with volunteers who took the lower dose of the test medicine (Group A).
The amount of test medicine in the blood was slightly higher when it was taken after a meal for both doses.
The amount of test medicine in the blood was similar for this study, which was using a new type of capsule (softgel), compared with a previous study which used the same doses of test medicine but in a hardgel capsule.
The test medicine was well tolerated in the healthy volunteers.Did the participants have any unwanted effects?
Yes.
Unwanted effects occurred in 7 out of the 16 volunteers who took the test medicine and 5 of these volunteers had unwanted effects that may have been caused by the test medicine.
The numbers of unwanted effects that may have been caused by the test medicine were similar in Group A and Group B.
All the unwanted effects after taking test medicine were mild, except for 1 volunteer who had an unwanted effect that was moderate; however, it was not related to the test medicine.
Overall, the most common unwanted effect thought to be caused by the test medicine was headache.Where can I find more information about this study?
For more information about the study, go to www.isrctn.com and search for the ISRCTN number: ISRCTN52169163.REC name
London - Chelsea Research Ethics Committee
REC reference
22/FT/0029
Date of REC Opinion
8 Mar 2022
REC opinion
Further Information Favourable Opinion