Single and Multiple Ascending Dose Study of CORT113176 in Healthy Participants

Healthy Adults Clinical Trial

Official title:

A Phase 1 Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered CORT113176 in Healthy Subjects, With an Optional Pharmacological Effects Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04249323
• Other study ID #: CORT113176-650
• Secondary ID: 2019-004258-27
• Status: Completed
• Phase: Phase 1
• Start date: January 27, 2020
• Est. completion date: October 15, 2020

Study information

• Verified date: January 2022
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple ascending doses (MAD; Part 2) of CORT113176 in healthy participants; Part 3 is an optional part to investigate whether CORT113176 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 pharmacokinetic (PK) and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 2 SAD levels to allow MAD administration in the fasted state, or until after a food-effect cohort has been dosed in the SAD phase to allow MAD administration in the fed state. The expected exposure for the daily MAD level at steady state (taking into consideration potential accumulation on repeat dosing) must not exceed the highest exposure considered to be safe and well tolerated during preceding SAD cohorts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) 18.0 to 30.0 kg/m^2, inclusive

• Body weight =102 kg

• Willing to consume a high-fat breakfast, including pork

• Agrees to adhere to the contraception requirements of the protocol

• Additional criteria apply.

Exclusion Criteria:

• Received any investigational drug or device in a clinical research study within the last 90 days

• History of any drug or alcohol abuse in the last 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 or nicotine replacement products in the last 6 months

• Female of childbearing potential, pregnant or breastfeeding

• Have a pregnant partner

• 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 or hepatic disease

• History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, gastrointestinal, neurological, or psychiatric disorder

• Any form of cancer in the last 5 years (exceptions apply)

• History of adrenal insufficiency

• Have a condition that could be aggravated by glucocorticoid and/or mineralocorticoid blockade

• Currently using glucocorticoids or a history of systemic glucocorticoid use in the last 12 months or 3 months for inhaled products

• Additional criteria apply.

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Drug:
• CORT113176 Lipid Capsule Formulation
CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration
• Placebo matching CORT113176 Lipid Capsule Formulation
Placebo matching CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration
• Prednisone
Prednisone standard release tablets 1 x 20 mg plus 1 x 5 mg for oral administration

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Ruddington	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Adverse Events		Part 1 SAD Cohorts: up to Day 9; Part 2 MAD Cohorts: up to Day 23; Part 3 Cohort: up to Day 19
Secondary	Maximum Plasma Concentration (Cmax) of CORT113176		Before dosing and at pre-specified time points up to Day 9 (Part 1 SAD Cohorts), up to Day 23 (Part 2 MAD Cohorts), or Days 10-19 (Part 3 Cohort)
Secondary	Time of Cmax (Tmax) of CORT113176		Before dosing and at pre-specified time points up to Day 9 (Part 1 SAD Cohorts), up to Day 23 (Part 2 MAD Cohorts), or Days 10-19 (Part 3 Cohort)
Secondary	Apparent Elimination Half-life (t1/2) of Plasma CORT113176		Before dosing and at pre-specified time points up to Day 9 (Part 1 SAD Cohorts), up to Day 23 (Part 2 MAD Cohorts), or Days 10-19 (Part 3 Cohort)
Secondary	Area Under the Plasma Concentration-time Curve (AUC) of CORT113176		Before dosing and at pre-specified time points up to Day 9 (Part 1 SAD Cohorts), up to Day 23 (Part 2 MAD Cohorts), or Days 10-19 (Part 3 Cohort)
Secondary	Serum Cortisol		Predose on Days 1 and 14 (Part 2 MAD Cohorts)
Secondary	Serum Adrenocorticotropic Hormone (ACTH)		Predose on Days 1 and 14 (Part 2 MAD Cohorts)