NCT02616445

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2015

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
Last Updated

January 22, 2025

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

November 5, 2015

Last Update Submit

January 20, 2025

Conditions

Healthy Volunteers

Keywords

Xanamememestedastat

Outcome Measures

Primary Outcomes (6)

  • Assess Safety and Tolerability of UE2343 over 17 days including AEs, 12-lead ECGs, vital signs, Nerve conduction velocity, Labs.

    Up to Day 17

  • Assess the Pharmacokinetic (PK) Plasma Parameter Maximum Plasma Concentration (Cmax) of UE2343 after a single dose

    Day 1 and Day 8

  • Assess the Pharmacokinetic (PK) Plasma Parameter Time to Cmax (Tmax) of UE2343 after a single dose

    Day 1 and Day 8

  • Assess the Pharmacokinetic (PK) Plasma Parameter Area Under the Curve (AUC) of UE2343 after a single dose

    Day 1 and Day 8

  • Assess the Pharmacokinetic (PK) Plasma Parameter Terminal Elimination Half Life (t½) of UE2343 after a single dose

    Day 1 and Day 8

  • Assess PK Parameter Maximum Plasma Concentration (Cmax) of UE2343 in CSF

    Day 4

Secondary Outcomes (14)

  • Assess Pharmacokinetics (PK) Plasma parameter Maximum Plasma Concentration (Cmax) from time of dosing to 12 hours

    Day 1 and Day 10

  • Assess Pharmacokinetics (PK) Plasma parameter Time to Cmax (Tmax) from time of dosing to 12 hours

    Day 1 and Day 10

  • Assess Pharmacokinetics (PK) Plasma parameter Area Under the Curve (AUC) from time of dosing to 12 hours

    Day 1 and Day 10

  • Assess Pharmacokinetics (PK) Plasma parameter Terminal Elimination Half Life (t½) from time of dosing to 12 hours

    Day 1 and Day 10

  • Assess Pharmacokinetics (PK) Urine parameters (Amount of drug excreted in urine (Ae) and Ae as a % of dose) from time of dosing to 24 hours

    Day 1 and Day 10

  • +9 more secondary outcomes

Study Arms (3)

MAD Study

PLACEBO COMPARATOR
Drug: UE2343Drug: Placebo

Fed-Fasted

PLACEBO COMPARATOR
Drug: PlaceboDrug: UE2343

CSF

EXPERIMENTAL
Drug: UE2343

Interventions

UE2343DRUG

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

MAD Study
PlaceboDRUG

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

MAD Study

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

Related Publications (1)

  • Webster SP, McBride A, Binnie M, Sooy K, Seckl JR, Andrew R, Pallin TD, Hunt HJ, Perrior TR, Ruffles VS, Ketelbey JW, Boyd A, Walker BR. Selection and early clinical evaluation of the brain-penetrant 11beta-hydroxysteroid dehydrogenase type 1 (11beta-HSD1) inhibitor UE2343 (Xanamem). Br J Pharmacol. 2017 Mar;174(5):396-408. doi: 10.1111/bph.13699. Epub 2017 Jan 25.

    PMID: 28012176BACKGROUND

MeSH Terms

Interventions

UE2343

Study Officials

  • Vincent Ruffles

    Actinogen Medical

    STUDY CHAIR

  • Janakan Krishnarajah

    Linear Clinical Research Limited

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 30, 2015

Study Start

February 1, 2015

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

January 22, 2025

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)