A 28 Day Parallel Group Study to Assess the Effects of RDN-929

Study Overview
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Brief Summary
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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.

Official Title
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A Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetic (PK) Profile of Multiple Oral Doses of RDN-929 in Healthy Older Adults

Conditions
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Healthy

Intervention / Treatment
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* Drug: RDN-929 oral capsule
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RDN-929<br>low, medium and high dose of RDN-929 capsules | Drug: RDN-929 oral capsule<br>* low, medium and high dose<br>|
| Placebo Comparator: Placebo<br>Matching placebo capsules | Drug: Placebo oral capsule<br>* matching placebo dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events | Screening to end of study, up to 9 weeks | up to 9 weeks | 
| Number of subjects with Physical exam findings | Screening to end of study, up to 9 weeks | up to 9 weeks | 
| Number of subjects with Clinical safety lab changes | Screening to end of study, up to 9 weeks | up to 9 weeks | 
| Number of subjects with Systolic blood pressure changes | Screening to end of study, up to 9 weeks | up to 9 weeks | 
| Number of subjects with Heart rate changes | Screening to end of study, up to 9 weeks | up to 9 weeks | 
| Number of subjects with 12 Lead ECG changes | Screening to end of study, up to 9 weeks | up to 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration, Cmax | RDN-929 and primary metabolite ROD-1610 | Day 1 to Day 28 | 
| Area Under the plasma and CSF concentration time curve, AUC | RDN-929 and primary metabolite ROD-1610 | Day 1 to Day 28 |