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Single and Multiple Ascending Dose Study of CORT125236 in Healthy Participants

NCT05003713 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-03-22

No results posted yet for this study

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 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.

Conditions

  • Healthy

Interventions

DRUG

CORT125236

CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration

DRUG

Placebo matching CORT125236

Placebo matching CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration

DRUG

Prednisone

Prednisone tablet 25 mg (20 mg + 5 mg tablets) for oral administration

Sponsors & Collaborators

  • Corcept Therapeutics

    lead INDUSTRY

Principal Investigators

  • Hazel Hunt, Ph.D. · Corcept Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-03
Primary Completion
2023-02-03
Completion
2023-02-03

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05003713 on ClinicalTrials.gov