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

Phase 1TerminatedNCT03963973

Alkermes, Inc.7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

RDN-929 oral capsuleDRUG

low, medium and high dose

Placebo oral capsuleDRUG

matching placebo dose

Eligibility

Sex: ALLMin age: 55 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Brain Research Center

Amsterdam, Netherlands

QPS Netherlands B.V.

Leeuwarden, Netherlands