Trial | NCT02616445  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ue2343 ...

  • Study Participants

    40
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.
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.
Study Started
Feb 28
2015
Primary Completion
Aug 31
2015
Study Completion
Sep 30
2015
Last Update
May 02
2017

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

MAD Study Placebo Comparator

Fed-Fasted Placebo Comparator

CSF Experimental

Criteria 

Inclusion Criteria:

Willing to use specified contraception
BMI within specified range
No clinically significant abnormalities in the results of laboratory evaluations at Screening and Day -1.

Exclusion Criteria:

Abnormal medical history, including history of dementia
No significant allergic reactions
No prior drug or alcohol abuse
Use of regular prescribed medication
No Results Posted