Single and Multiple Ascending Dose Study of CORT125329 in Healthy Participants
NCT04672512 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 115
Last updated 2022-02-09
Summary
The purpose of this study is to evaluate the dose-related safety, tolerability, pharmacokinetics (PK) and pharmacological effects (PD) of CORT125329 after single and multiple ascending oral doses of CORT125329 lipid capsule formulations in healthy participants.
Conditions
- Healthy
Interventions
- DRUG
-
CORT125329 lipid capsule formulation
CORT125329 lipid capsule formulation 1 or 2 for oral administration
- DRUG
-
Placebo matching CORT125329 lipid capsule formulation 1 or 2 for oral administration
- DRUG
-
Prednisone tablet for oral administration
Sponsors & Collaborators
-
Corcept Therapeutics
lead INDUSTRY
Principal Investigators
-
Sharan Sidhu, MBChB, BAO, MRCS, MFPM · Quotient Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-10-23
- Primary Completion
- 2022-01-17
- Completion
- 2022-01-17
Countries
- United Kingdom
Study Locations
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