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Single and Multiple Ascending Dose Study of CORT113176 in Healthy Participants

NCT04249323 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-02-01

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 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.

Conditions

  • Healthy Adults

Interventions

DRUG

CORT113176 Lipid Capsule Formulation

CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration

DRUG

Placebo matching CORT113176 Lipid Capsule Formulation

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

DRUG

Prednisone

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

Sponsors & Collaborators

  • Corcept Therapeutics

    lead INDUSTRY

Principal Investigators

  • Sharan Sidhu, MBChb, BAO, MRCS, MFPM · Quotient Sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-01-27
Primary Completion
2020-10-15
Completion
2020-10-15

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 NCT04249323 on ClinicalTrials.gov