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drugset / Trial / NCT03315338

First-in-human Study in Healthy Subjects

NCT03315338 ↗

Phase 1 Completed 143 enrolled Corcept Therapeutics
RandomizedParallel-groupTriple-blindBasic science

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.

Timeline

Start
2017-09-15
Primary completion
2019-02-22
Completion
2019-02-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Miricorilant Small molecule 25 mg Oral
Subject Miricorilant Small molecule 75 mg Oral
Subject Miricorilant Small molecule 100 mg Oral
Subject Miricorilant Small molecule 150 mg Oral
Subject Miricorilant Small molecule 225 mg Oral
Subject Miricorilant Small molecule 300 mg Oral
Subject Miricorilant Small molecule 375 mg Oral
Subject Miricorilant Small molecule 600 mg Oral
Subject Miricorilant Small molecule 630 mg Oral
Subject Miricorilant Small molecule 675 mg Oral
Subject Miricorilant Small molecule 900 mg Oral
Subject Miricorilant Small molecule 1500 mg Oral
Background Glucose Unknown 75 g Oral
Background Prednisone Oral Tablet Unknown 25 mg Oral

Indications

No indication recorded.