drugset / Trial / NCT03335956
CORT125281 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.