amyotrophic lateral sclerosis (ALS)
Conditions
Interventions
The planned dose levels for the study are as follows:
Group 1 - Day 1 to 14 - Treatment: CORT113176 150 mg or placebo - How often:
once daily (14 times in total)
Group 2 - Day 1 to 14 - Treatment: C
Sponsors
Corcept Therapeutics Incorporated
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects. 2. Age 18 to 65 years inclusive at the time of signing informed consent (ICF). 3. Body mass index (BMI) of >=18.0 to =200,000/µL; international normalized ratio (INR) and activated partial thromboplastin time (aPTT) within normal laboratory ranges at screening and Day -1. The other subjects must show a platelet count above the lower limit of the normal laboratory range at screening and Day -1. 6. Must be willing and able to communicate with the study personnel, and participate in the whole study. 7. Willing and able to provide an ICF.
Exclusion criteria
Exclusion criteria: 1. Subjects who have received any IMP in a clinical research study within the 90 days before the first dose in this study. 2. Unable to swallow a test medicine of the size of the CORT113176 capsules 3. Subjects who are CRU or sponsor employees, or immediate family members of a CRU or sponsor employee. 4. Subjects who have previously been enrolled in this study. Subjects are only allowed to take part in one study part. 5. History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: AEs, clinical laboratory tests, vital signs, 12-lead ECGS, physical examinations Pharmacokinetics: Plasma CORT113176 concentrations and PK parameters, CSF CORT113176 concentrations Exploratory: Concentration of cortisol in serum. | — |
Countries
Netherlands
Outcome results
None listed