NCT03411421

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Dosing Regimens of AL-794 in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Dosing Regimens of AL-794 in Healthy Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Alios Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability (including incidence of central nervous system \[CNS\] related events such as lightheadedness and dizziness), of multiple oral doses of AL-794 in healthy volunteers (HV). Also, to evaluate the pharmacokinetics of ALS-033719 and ALS-033927 in plasma after multiple oral doses of AL-794 in HV.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AL-794	AL-794 will be administered as tablets orally on Day 1 to Day 5.
DRUG	Placebo	Matching placebo tablets will be administered.

Timeline

• Start date: 2018-03-03
• Primary completion: 2018-04-27
• Completion: 2018-04-27
• First posted: 2018-01-26
• Last updated: 2025-02-03

Locations

1 site across 1 country: United Kingdom