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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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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

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MAD Study

Group Type PLACEBO_COMPARATOR

UE2343

Intervention Type DRUG

* UE2343
* 10mg, 20, 35mg
* twice daily for 9 days

Placebo

Intervention Type DRUG

* 10mg, 20, 35mg
* twice daily for 9 days

Fed-Fasted

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

* Cross-over study
* single dose administered twice (on day 1 and day 8)
* study duration 17 days

UE2343

Intervention Type DRUG

* Cross-over study
* UE2343
* single dose administered twice (on day 1 and day 8)
* study duration 17 days

CSF

Group Type EXPERIMENTAL

UE2343

Intervention Type DRUG

* UE2343
* twice daily for 3 days
* single dose on day 4

Interventions

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UE2343

* UE2343
* 10mg, 20, 35mg
* twice daily for 9 days

Intervention Type DRUG

Placebo

* 10mg, 20, 35mg
* twice daily for 9 days

Intervention Type DRUG

Placebo

* Cross-over study
* single dose administered twice (on day 1 and day 8)
* study duration 17 days

Intervention Type DRUG

UE2343

* Cross-over study
* UE2343
* single dose administered twice (on day 1 and day 8)
* study duration 17 days

Intervention Type DRUG

UE2343

* UE2343
* twice daily for 3 days
* single dose on day 4

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes