Single and Multiple Ascending Dose Study of CORT125236 in Healthy Participants
Summary
This is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple ascending doses (MAD; Part 2) of CORT125236 in healthy participants; Part 3 is optional, to investigate whether CORT125236 ameliorates the effects of prednisone on various pharmacodynamic (PD) endpoints. The 3 parts may not be conducted entirely sequentially provided that this is justified by the pharmacokinetic (PK) and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 3 SAD levels to allow MAD administration to proceed. The decision on whether to start Part 3 can be made at any point after completion of 3 SAD levels, and will be based on achieving sufficiently high plasma CORT125236 exposure in Part 1 of the study.
Timeline
- Start
- 2021-08-03
- Primary completion
- 2023-02-03
- Completion
- 2023-02-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CORT125236 | Unknown | 10 mg | Oral |
| Subject | CORT125236 | Unknown | 20 mg | Oral |
| Subject | CORT125236 | Unknown | 60 mg | Oral |
| Background | Prednisone | Other / unclassified | 25 mg | Oral |
Indications
No indication recorded.