NCT03668314

Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly Subjects

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Doses of Orally Administered RDN-929 in Healthy Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

A three (3) part study to evaluate the safety, tolerability and PK of RDN-929

Detailed description

Part 1 (Randomized, Double Blind): Up to 6 single ascending doses of RDN-929 are planned to be tested in 6 cohorts of 8 healthy males (Cohort 1:1 to 1:6). Within each cohort subjects will be randomly assigned to receive either a single dose of RDN-929 (6 subjects) or matched placebo (2 subjects). Part 2 (Open): Part 2 will consist of 2 crossover treatment periods in one cohort of 12 healthy elderly subjects (at least 3 of each gender), aged 55-80 years. The treatments will be separated by a washout period of at least 7 days. The dose selected for this part of the study will be based on the results of Part 1. In Period 1, subjects will be randomized to receive a single dose of RDN-929 in either fasted or fed status. In Period 2, subjects will receive a single dose of RDN-929 under the alternate status. Part 3 (Randomized, Double Blind): Multiple ascending doses (MAD) of RDN-929 are planned to be tested in up to 4 cohorts of 8 healthy elderly subjects (at least 3 of each gender per dose level cohort), aged 55-80 years. The doses will be selected by the safety review committee (SRC) based on all available safety, tolerability and PK data and after approval by the ethics committee. Within each cohort subjects will be randomly assigned to receive either, RDN-929 once daily (6 subjects) or matched placebo (2 subjects) once daily for 12 days. Escalation to the next higher dose level will be based upon a review of the safety and tolerability data.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	RDN-929	Single dose from 2 mg to TBD
DRUG	Placebo oral capsule	Matching placebo Single dose
DRUG	RDN-929 TBD dose	Fed vs fast dose TBD based upon results of previous cohorts
DRUG	RDN-929	Multiple dose based on results of previous cohorts
DRUG	Placebo oral capsule	Matching placebo multiple dose

Timeline

• Start date: 2018-10-10
• Primary completion: 2019-04-15
• Completion: 2019-04-15
• First posted: 2018-09-12
• Last updated: 2020-02-20

Locations

1 site across 1 country: Netherlands