Healthy
Conditions
Brief summary
Eligibility will be assessed during a screening period of up to 4 weeks. Subjects will take study medication once daily up to and including Day 28. Safety, tolerability and PK will be measured at each visit.
Interventions
DRUGRDN-929 oral capsule
low, medium and high dose
DRUGPlacebo oral capsule
matching placebo dose
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult males or postmenopausal or surgically sterile females age 55 - 85 years old. * Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests and ECG recording
Exclusion criteria
* Any history of major psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal (ULN) * A clinically significant abnormality on physical examination, neurological examination, ECG, or laboratory evaluations * A clinically significant vital signs abnormality, as judged by the principal investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with 12 Lead ECG changes | up to 9 weeks | Screening to end of study, up to 9 weeks |
| Number of subjects with Systolic blood pressure changes | up to 9 weeks | Screening to end of study, up to 9 weeks |
| Number of subjects with Heart rate changes | up to 9 weeks | Screening to end of study, up to 9 weeks |
| Number of subjects with adverse events | up to 9 weeks | Screening to end of study, up to 9 weeks |
| Number of subjects with Physical exam findings | up to 9 weeks | Screening to end of study, up to 9 weeks |
| Number of subjects with Clinical safety lab changes | up to 9 weeks | Screening to end of study, up to 9 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the plasma and CSF concentration time curve, AUC | Day 1 to Day 28 | RDN-929 and primary metabolite ROD-1610 |
| Maximum observed plasma concentration, Cmax | Day 1 to Day 28 | RDN-929 and primary metabolite ROD-1610 |
Countries
Netherlands
Outcome results
None listed