NCT02616445

Phase I MAD, Fed-Fasted, CSF Study of UE2343 in Healthy Subjects

A Phase I Double-Blind, Randomised, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UE2343 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Actinogen Medical · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether the drug UE2343, a potential treatment for Alzheimer's Disease (AD), is effective by assessing safety, tolerability, pharmacokinetics and pharmacodynamics in a Multiple Ascending Dose Study. Protocol amendments to the study will examine any food effect and determine if the drug penetrates the Blood-Brain Barrier.

Detailed description

Part 1 of this study is a double-blind, randomised, placebo-controlled, multiple ascending dose study to assess the safety, tolerability, PK and PD in healthy participants dosed twice daily at levels of 10, 20 and 35mg for 10 days.This part of the study will recruit 3 groups of 8 participants each. Part 2 is a cross-over study to assess the effects of food on the PK of UE2343 in healthy participants dosed with two single doses at a level decided from Part 1. This part of the study will recruit a total of 12 participants. Part 3 seeks to determine the PK of the UE2343 in CSF of healthy participants dosed twice daily for 4 days with a dose level determined from Part 1 and 2. This part of the study will recruit 4 participants. Strategies to ensure adherence to the study include the requirement that participants remain at the clinical research facility for the duration of their participation in the study; drug accountability checks (i.e. reconciliation of used and unused capsules) by an independent clinical research associate; and administration of the capsules to the participant by a member of the study site team.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	UE2343	* UE2343 * 10mg, 20, 35mg * twice daily for 9 days
DRUG	Placebo	* 10mg, 20, 35mg * twice daily for 9 days
DRUG	Placebo	* Cross-over study * single dose administered twice (on day 1 and day 8) * study duration 17 days
DRUG	UE2343	* Cross-over study * UE2343 * single dose administered twice (on day 1 and day 8) * study duration 17 days
DRUG	UE2343	* UE2343 * twice daily for 3 days * single dose on day 4

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2015-11-30
• Last updated: 2025-01-22

Locations

1 site across 1 country: Australia