CORT125281 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)

Summary

This initial Phase I study will evaluate the dose-related safety and tolerability pharmacokinetics (PK) of CORT125281, and CORT125324 (active metabolite), and pharmacodynamics (PD) after single and multiple ascending oral doses of CORT125281 in healthy subjects.

Conditions

• Healthy

Interventions

DRUG

CORT125281, 40mg, fasted

CORT125281 is supplied as capsules for oral dosing

DRUG

Prednisone 25mg, fasted

Challenge Agent, Dose and Route of Administration: Standard release 25 mg tablets, orally administered

DRUG

Placebo oral capsule, fasted

Reference Therapy, Dose and Route of Administration: Placebo capsule, orally administered

DRUG

Pioglitazone 15mg Tablet

Probe Substrate, Dose and Route of Administration: 15 Mg tablet, orally administered

DRUG

Placebo oral capsule, fed

Reference Therapy, Dose and Route of Administration: Placebo capsule, orally administered

DRUG

Prednisone 25mg, fed

Challenge Agent, Dose and Route of Administration: Standard release 25 mg tablets, orally administered

DRUG

CORT125281, 120mg, fasted

CORT125281 is supplied as capsules for oral dosing

DRUG

CORT125281, 360mg, fasted

CORT125281 is supplied as capsules for oral dosing

DRUG

CORT125281, 720mg, fasted

CORT125281 is supplied as capsules for oral dosing

DRUG

CORT125281, 360mg, fed

CORT125281 is supplied as capsules for oral dosing

DRUG

CORT125281, 360mg

CORT125281 is supplied as capsules for oral dosing twice, 12 hours apart, fasted (morning) and after evening meal

DRUG

CORT125281, 120mg

CORT125281 is supplied as capsules for oral dosing once daily

DRUG

CORT125281, 180mg

CORT125281 is supplied as capsules for oral dosing twice daily

DRUG

CORT125281, 240mg

CORT125281 is supplied as capsules for oral dosing twice daily

DRUG

CORT125281, 360mg

CORT125281 is supplied as capsules for oral dosing once daily

DRUG

Placebo oral capsule

Reference Therapy, Dose and Route of Administration: Placebo capsule, orally administered twice, 12 hours apart, fasted (morning) and after evening meal

DRUG

Placebo oral capsule

Reference Therapy, Dose and Route of Administration: Placebo capsule, orally administered, twice daily

DRUG

Placebo oral capsule

Reference Therapy, Dose and Route of Administration: Placebo capsule, orally administered, once daily

Sponsors & Collaborators

• Corcept Therapeutics

  lead INDUSTRY

Principal Investigators

• Stacie Shepherd, M.D., Ph.D. · Corcept Therapeutics

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-09-21

Primary Completion

2018-05-31

Completion

2018-06-25

Countries

• United Kingdom

Study Locations