Who is sponsoring NCT03508635?

NCT03508635 is sponsored by Corcept Therapeutics.

What drugs are being tested in NCT03508635?

Interventions: CORT125134, Matching Placebo of CORT125134, Mifepristone, Prednisone, Glucose.

What is the status of NCT03508635?

NCT03508635 is currently COMPLETED.

Last reviewed 2019-08-07 · How we verify

A Phase I Adaptive Dose, Double-Blind, Placebo-Controlled, SAD and MAD Study to Measure the Safety, Tolerability, Pharmacokinetics and Pharmacological Effects of Orally Administered CORT125134 in Healthy Subjects

NCT03508635 Phase 1 COMPLETED

The purpose of this study is to evaluate the dose-related safety, tolerability, pharmacokinetics (PK) and pharmacological effects (PD) of CORT125134 and its active metabolite CORT125201 after single and multiple ascending oral doses of CORT125134 in healthy participants.

Details

Lead sponsor	Corcept Therapeutics
Phase	Phase 1
Status	COMPLETED
Enrolment	130
Start date	2014-09
Completion	2015-12

Conditions

Healthy

Interventions

CORT125134
Matching Placebo of CORT125134
Mifepristone
Prednisone
Glucose

Primary outcomes

Incidence of Treatment-Emergent Adverse Events (AEs) (Safety and Tolerability) of CORT125134 — Single dose Cohorts 1-9 Day 1 to Day 15; MAD Cohorts 10-13 Day 1 to Day 28/Day 24 (Cohort 13)

Countries

United Kingdom