Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Corcept Therapeutics
+1 650-327-3270
clinicalstudies@corcept.com


Hazel Hunt, Ph.D.
+1 650-688-2862
hhunt@corcept.com


Study Location:

Site 01
Ruddington
Nottingham
NG11 6JS


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Single and Multiple Ascending Dose Study of CORT125236 in Healthy Participants

Recruiting

Open to: All Genders

Age: 18 Years - 60 Years

Medical Conditions

Healthy


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




This is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple ascending doses (MAD; Part 2) of CORT125236 in healthy participants; Part 3 is optional, to investigate whether CORT125236 ameliorates the effects of prednisone on various pharmacodynamic (PD) endpoints. The 3 parts may not be conducted entirely sequentially provided that this is justified by the pharmacokinetic (PK) and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 3 SAD levels to allow MAD administration to proceed. The decision on whether to start Part 3 can be made at any point after completion of 3 SAD levels, and will be based on achieving sufficiently high plasma CORT125236 exposure in Part 1 of the study.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2021

Nov 2022

Interventional

Intervention Type : Drug
Intervention Description : CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration

Intervention Arm Group : Part 1: SAD Cohorts A through F CORT125236;Part 2: MAD Cohorts A through D CORT125236;Part 3: Single Dose Pharmacodynamic Effect

Intervention Type : Drug
Intervention Description : Placebo matching CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration

Intervention Arm Group : Part 1: SAD Cohorts A through F Placebo;Part 2: MAD Cohorts A through D Placebo

Intervention Type : Drug
Intervention Description : Prednisone tablet 25 mg (20 mg + 5 mg tablets) for oral administration

Intervention Arm Group : Part 3: Single Dose Pharmacodynamic Effect

You can take part if:


Inclusion Criteria: - Body mass index 18.0 to 30.0 kg/m^2, inclusive - Body weight ≤102 kg - Willing to consume a high-fat breakfast, including pork - Adheres to the contraception requirements of the protocol - Additional criteria apply. Exclusion Criteria: - Received any investigational drug or device in a clinical research study within 90 days - Evidence of current severe acute respiratory syndrome (SARS-CoV-2) infection - History of any drug or alcohol abuse in the past 2 years; a confirmed positive drugs of abuse test result - Regular alcohol consumption; a confirmed positive alcohol breath test at screening - Current smoker; a confirmed positive breath carbon monoxide reading; current user of e-cigarettes and nicotine replacement products in the last 6 months - Female of childbearing potential, pregnant, or breastfeeding - Male participant with pregnant or lactating partners - Clinically significant abnormal clinical chemistry, hematology or urinalysis result - Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) - Active renal and/or hepatic disease - History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, gastrointestinal (GI), neurological or psychiatric disorder - Any form of cancer in the 5 years (exceptions apply) - History of adrenal insufficiency - Have a condition that could be aggravated by glucocorticoid antagonism - Donation or loss of greater than 400 mL of blood or plasma within the previous 3 months - Currently using glucocorticoids or have a history of systemic glucocorticoid use in the last 12 months or 3 months for inhaled products - Additional criteria apply.




You may not be able to take part if:

This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Site 01
    Ruddington
    Nottingham
    NG11 6JS


The study is sponsored by Corcept Therapeutics



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for Trial ID: NCT05003713

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