Single and Multiple Ascending Dose Study of CORT125329 in Healthy Participants

NCT04672512 | Completed Phase 1

• 2 other identifiers: CORT125329-1402020-001741-38
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the dose-related safety, tolerability, pharmacokinetics (PK) and pharmacological effects (PD) of CORT125329 after single and multiple ascending oral doses of CORT125329 lipid capsule formulations in healthy participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants with One or More Adverse Events

  SAD Cohorts: up to Day 11; MAD Cohorts: up to Day 23; PD Effect Cohort: up to Day 2 in Period 1 and up to Day 11 in Period 2

• Percentage of Participants with One or More Serious Adverse Events

  SAD Cohorts: up to Day 11; MAD Cohorts: up to Day 23; PD Effect Cohort: up to Day 2 in Period 1 and up to Day 11 in Period 2

• Percentage of Participants Discontinued from the Study Due to an Adverse Event

  SAD Cohorts: up to Day 11; MAD Cohorts: up to Day 23; PD Effect Cohort: up to Day 2 in Period 1 and up to Day 11 in Period 2

Secondary Outcomes (13)

• Plasma Pharmacokinetics (PK) of CORT125329: Maximum Observed Concentration (Cmax)

  SAD Cohorts: before dosing and at prespecified time points up to Day 11; MAD Cohorts: before dosing and at prespecified time points up to Day 23; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2

• Plasma PK of CORT125329: Elapsed Time from Dosing at which the Analyte was First Quantifiable in a Concentration vs Time Profile (tlag)

  SAD Cohorts: before dosing and at prespecified time points up to Day 11; MAD Cohorts: before dosing and at prespecified time points up to Day 23; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2

• Plasma PK of CORT125329: Time from Dosing at which Cmax was Apparent (Tmax)

  SAD Cohorts: before dosing and at prespecified time points up to Day 11; MAD Cohorts: before dosing and at prespecified time points up to Day 23; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2

• Plasma PK of CORT125329: Apparent Elimination Half-life (t1/2)

  SAD Cohorts: before dosing and at prespecified time points up to Day 11; MAD Cohorts: before dosing and at prespecified time points up to Day 23; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2

• Plasma PK of CORT125329: Area Under the Curve from Zero Time to the Last Measurable Concentration (AUC0-last)

  SAD Cohorts: before dosing and at prespecified time points up to Day 11; PD Effect Cohort: before dosing and at prespecified time points up to Day 11 in Period 2

Study Arms (7)

SAD Cohort A CORT125329

EXPERIMENTAL

Participants will receive a single dose of CORT125329 30 mg lipid capsule formulation 1 in the fasted state on Day 1

Drug: CORT125329 lipid capsule formulation

SAD Cohort B CORT125329

EXPERIMENTAL

Participants will receive a single dose of CORT125329 lipid capsule formulation 1 in the fasted state on Day 1. The dose will be determined after review of safety, tolerability, and PK data from SAD Cohort A.

Drug: CORT125329 lipid capsule formulation

SAD Cohorts C through H CORT125329

EXPERIMENTAL

Participants will receive a single dose of CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Day 1 in a dose escalation format. The dose, formulation, and prandial state for each cohort will be determined after review of safety, tolerability, and PK data from previous cohorts.

Drug: CORT125329 lipid capsule formulation

SAD Cohorts A through H Placebo

PLACEBO COMPARATOR

Participants will receive a single dose of placebo matching CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Day 1 in a dose escalation format. The dose, formulation, and prandial state for each placebo cohort will match that used in the corresponding CORT125329 cohort.

Drug: Placebo

MAD Cohorts A through D CORT125329

EXPERIMENTAL

Participants will receive CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Days 1 through 14 in a dose escalation format. The dose, dose frequency (once- or twice-daily), formulation, and prandial state for each cohort will be determined after review of safety, tolerability, and PK data from previous cohorts.

Drug: CORT125329 lipid capsule formulation

MAD Cohorts A through D Placebo

PLACEBO COMPARATOR

Participants will receive placebo matching CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Days 1 through 14 in a dose escalation format. The dose, dose frequency, formulation, and prandial state for each cohort will match that used in the corresponding CORT125329 cohort.

Drug: Placebo

Pharmacodynamic (PD) Effect Cohort

EXPERIMENTAL

Participants will receive a single dose of prednisone 25 mg in the fasted or fed state on Day 1 of Period 1. The prandial state for the Period 1 treatment will be determined after review of safety and tolerability data from the SAD Cohorts. After a 7-day washout period, participants will receive a single dose of prednisone 25 mg and a single dose of CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Day 1 of Period 2. The formulation and dose level of CORT125329 treatment in Period 2 will be determined after review of safety, tolerability, and PK data from the SAD cohorts. The prandial state for treatment in Period 2 will be the same used in Period 1.

Drug: CORT125329 lipid capsule formulation; Drug: Prednisone

Interventions

CORT125329 lipid capsule formulation DRUG

CORT125329 lipid capsule formulation 1 or 2 for oral administration

MAD Cohorts A through D CORT125329; Pharmacodynamic (PD) Effect Cohort; SAD Cohort A CORT125329; SAD Cohort B CORT125329; SAD Cohorts C through H CORT125329

Placebo DRUG

Placebo matching CORT125329 lipid capsule formulation 1 or 2 for oral administration

MAD Cohorts A through D Placebo; SAD Cohorts A through H Placebo

Prednisone DRUG

Prednisone tablet for oral administration

Pharmacodynamic (PD) Effect Cohort

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index of 18.0 to 30.0 kg/m\^2
• Weight of ≤102 kg
• Must agree to adhere to the contraception requirements
• Additional criteria apply.

You may not qualify if:

• Received any investigational medicinal product in a clinical research study within the 90 days
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption
• Current smokers and those who have smoked within the last 6 months
• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months
• Females of childbearing potential including those who are pregnant or lactating (all female subjects must have a negative pregnancy test at screening and admission)
• Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the Investigator
• Confirmed positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• Active renal and/or hepatic disease
• History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, GI, neurological or psychiatric disorder, as judged by the Investigator
• Any form of cancer within the last 5 years (exceptions apply)
• History and/or symptoms of adrenal insufficiency
• History of clinically significant gastrointestinal disease
• Has a condition that could be aggravated by glucocorticoid antagonism

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (1)

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

Dosage Forms; Prednisone

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sharan Sidhu, MBChB, BAO, MRCS, MFPM

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 17, 2020
• Study Start: October 23, 2020
• Primary Completion: January 17, 2022
• Study Completion: January 17, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)