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Completed

NCT Number: NCT04249323

Single and Multiple Ascending Dose Study of CORT113176 in Healthy Participants

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.

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Key information

Conditions

Healthy Adults

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CORT113176 Lipid Capsule Formulation

Drug

CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration

Placebo matching CORT113176 Lipid Capsule Formulation

Drug

Placebo matching CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration

Prednisone

Drug

Prednisone standard release tablets 1 x 20 mg plus 1 x 5 mg for oral administration

Primary outcomes

  1. Number of Participants with One or More Adverse Events

    Time frame: Part 1 SAD Cohorts: up to Day 9; Part 2 MAD Cohorts: up to Day 23; Part 3 Cohort: up to Day 19

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) of CORT113176

    Time frame: 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)

  2. Time of Cmax (Tmax) of CORT113176

    Time frame: 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)

  3. Apparent Elimination Half-life (t1/2) of Plasma CORT113176

    Time frame: 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)

  4. Area Under the Plasma Concentration-time Curve (AUC) of CORT113176

    Time frame: 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)

  5. Serum Cortisol

    Time frame: Predose on Days 1 and 14 (Part 2 MAD Cohorts)

  6. Serum Adrenocorticotropic Hormone (ACTH)

    Time frame: Predose on Days 1 and 14 (Part 2 MAD Cohorts)

Sponsors and collaborators

Lead sponsor

Corcept Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2020
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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