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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: Placebo oral capsule; Drug: RDN-929 oral capsule

• Registration Number: NCT03963973
• Lead Sponsor: Alkermes, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-16
• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-28
• Primary Completion: 2020-01-22
• Study Completion: 2020-01-22
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral capsule	Matching placebo capsules
RDN-929	RDN-929 oral capsule	low, medium and high dose of RDN-929 capsules

Primary Outcome Measures

Name	Time	Method
Number of subjects with Systolic blood pressure changes	up to 9 weeks	Screening to end of study, up to 9 weeks
Number of subjects with Clinical safety lab changes	up to 9 weeks	Screening to end of study, up to 9 weeks
Number of subjects with adverse events	up to 9 weeks	Screening to end of study, up to 9 weeks
Number of subjects with Physical exam findings	up to 9 weeks	Screening to end of study, up to 9 weeks
Number of subjects with Heart rate changes	up to 9 weeks	Screening to end of study, up to 9 weeks
Number of subjects with 12 Lead ECG changes	up to 9 weeks	Screening to end of study, up to 9 weeks

Secondary Outcome Measures

Name	Time	Method
Area Under the plasma and CSF concentration time curve, AUC	Day 1 to Day 28	RDN-929 and primary metabolite ROD-1610
Maximum observed plasma concentration, Cmax	Day 1 to Day 28	RDN-929 and primary metabolite ROD-1610

Trial Locations

Locations (2)

Brain Research Center; 🇳🇱 Amsterdam, Netherlands

QPS Netherlands B.V.; 🇳🇱 Leeuwarden, Netherlands