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

NCT03963973 | Terminated Phase 1

• 1 other identifier: RDN-929-103
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Maximum observed plasma concentration, Cmax

  Day 1 to Day 28

• Area Under the plasma and CSF concentration time curve, AUC

  Day 1 to Day 28

Study Arms (2)

RDN-929

EXPERIMENTAL

low, medium and high dose of RDN-929 capsules

Drug: RDN-929 oral capsule

Placebo

PLACEBO COMPARATOR

Matching placebo capsules

Drug: Placebo oral capsule

Interventions

RDN-929 oral capsule DRUG

low, medium and high dose

RDN-929

Placebo oral capsule DRUG

matching placebo dose

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (2)

Brain Research Center

Amsterdam, Netherlands

Location

QPS Netherlands B.V.

Leeuwarden, Netherlands

Location

Study Officials

• PI

  QPS Holdings LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: May 16, 2019
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)