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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03963973
• Other study ID #: RDN-929-103
• Status: Terminated
• Phase: Phase 1
• Start date: May 16, 2019
• Est. completion date: January 22, 2020

Study information

• Verified date: February 2020
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 22, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• RDN-929 oral capsule
low, medium and high dose
• Placebo oral capsule
matching placebo dose

Locations

Country	Name	City	State
Netherlands	Brain Research Center	Amsterdam
Netherlands	QPS Netherlands B.V.	Leeuwarden

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

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