drugset / Trial / NCT03335956

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

NCT03335956

Phase 1 Completed 48 enrolled Corcept Therapeutics
RandomizedParallel-groupTriple-blindBasic science

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.

Timeline

Start
2017-09-21
Primary completion
2018-05-31
Completion
2018-06-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Exicorilant Small molecule 40 mg Oral
Subject Exicorilant Small molecule 120 mg Oral
Subject Exicorilant Small molecule 180 mg Oral
Subject Exicorilant Small molecule 240 mg Oral
Subject Exicorilant Small molecule 360 mg Oral
Subject Exicorilant Small molecule 720 mg Oral
Subject Pioglitazone Small molecule 15 mg Oral
Background Prednisone Other / unclassified 25 mg Oral

Indications

No indication recorded.