First-in-human Study in Healthy Subjects

Summary

This initial Phase I study will evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending doses of CORT118335, the effect of concomitant administration with food on exposure to CORT118335, and its pharmacological effect in healthy subjects.

Conditions

• Healthy

Interventions

DRUG

CORT118335, 25 mg

CORT118335 is supplied as capsules for oral dosing

DRUG

Prednisone Oral Tablet

Challenge Agent, Dose and Route of Administration: Standard release 1x20mg and 1x5mg (25mg total) dose, orally administered.

DRUG

Glucose

75 g in 300 mL solution, orally administered

DRUG

Placebo oral suspension

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

DRUG

CORT118335, 75mg

CORT118335 is supplied as capsules for oral dosing

DRUG

CORT118335, 225mg

CORT118335 is supplied as capsules for oral dosing

DRUG

CORT118335, 675mg

CORT118335 is supplied as capsules for oral dosing

DRUG

CORT118335, 600mg

CORT118335 is supplied as capsules for oral dosing

DRUG

CORT118335, 630mg

CORT118335 is supplied as capsules for oral dosing

DRUG

CORT118335, 375mg

CORT118335 is supplied as capsules for oral dosing

DRUG

CORT118335, 100mg

CORT118335 is supplied as a suspension for oral dosing

DRUG

CORT118335, 300mg

CORT118335 is supplied as a suspension for oral dosing

DRUG

CORT118335, 900mg

CORT118335 is supplied as a suspension for oral dosing

DRUG

CORT118335, 150mg

CORT118335 is supplied as a suspension for oral dosing

DRUG

CORT118335, 1500mg

CORT118335 is supplied as a suspension for oral dosing

DRUG

Placebo oral capsule

Placebo capsules, orally administered

DRUG

CORT118335, dose to be determined

CORT118335 is supplied as suspension for oral dosing

Sponsors & Collaborators

• Corcept Therapeutics

  lead INDUSTRY

Principal Investigators

• Stuart Mair, MBChB, MFPM · Quotient Clinical

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-09-15

Primary Completion

2019-02-22

Completion

2019-02-22

Countries

• United Kingdom

Study Locations