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

Alkermes

Status and phase

Terminated

Phase 1

Conditions

Healthy

Treatments

Drug: RDN-929 oral capsule

Drug: Placebo oral capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT03963973

RDN-929-103

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

55 to 85 years old

Volunteers

Accepts Healthy Volunteers

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