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

Actinogen Medical

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: UE2343

Study type: Interventional

Funder types: Industry

Identifiers

NCT02616445

ACW0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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40 participants in 3 patient groups, including a placebo group

MAD Study

Placebo Comparator group

Treatment:

Drug: UE2343

Drug: UE2343

Drug: UE2343

Drug: Placebo

Drug: Placebo

Fed-Fasted

Placebo Comparator group

Treatment:

Drug: UE2343

Drug: UE2343

Drug: UE2343

Drug: Placebo

Drug: Placebo

CSF

Experimental group

Treatment:

Drug: UE2343

Drug: UE2343

Drug: UE2343