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

February 19, 2020 updated by: Alkermes, Inc.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Brain Research Center
      • Leeuwarden, Netherlands
        • QPS Netherlands B.V.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Matching placebo capsules
Drug: Placebo oral capsule
matching placebo dose
EXPERIMENTAL: RDN-929
low, medium and high dose of RDN-929 capsules
Drug: RDN-929 oral capsule
low, medium and high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with adverse events
Time Frame: up to 9 weeks
Screening to end of study, up to 9 weeks
up to 9 weeks
Number of subjects with Physical exam findings
Time Frame: up to 9 weeks
Screening to end of study, up to 9 weeks
up to 9 weeks
Number of subjects with Clinical safety lab changes
Time Frame: up to 9 weeks
Screening to end of study, up to 9 weeks
up to 9 weeks
Number of subjects with Systolic blood pressure changes
Time Frame: up to 9 weeks
Screening to end of study, up to 9 weeks
up to 9 weeks
Number of subjects with Heart rate changes
Time Frame: up to 9 weeks
Screening to end of study, up to 9 weeks
up to 9 weeks
Number of subjects with 12 Lead ECG changes
Time Frame: up to 9 weeks
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
Time Frame: Day 1 to Day 28
RDN-929 and primary metabolite ROD-1610
Day 1 to Day 28
Area Under the plasma and CSF concentration time curve, AUC
Time Frame: Day 1 to Day 28
RDN-929 and primary metabolite ROD-1610
Day 1 to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 16, 2019

Primary Completion (ACTUAL)

January 22, 2020

Study Completion (ACTUAL)

January 22, 2020

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (ACTUAL)

May 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • RDN-929-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on RDN-929 oral capsule

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe