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Healthy VolunteersPhase 1NCT02616445

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

A Phase 1 study testing UE2343 in people with Healthy Volunteers, run by Actinogen Medical at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
UE2343
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteAustralia
Study dates
Feb 2015to Sep 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Linear Clinical Research

    Nedlands, Western Australia, 6009

Other trials in Australia

About this study

Official title: 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

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.

Read the 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.

Being tested
UE2343, Placebo
Keywords
Xanamem, emestedastat

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UE2343Drug

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

  • PlaceboDrug

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

  • PlaceboDrug

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

  • UE2343Drug

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

  • UE2343Drug

    • UE2343
    • twice daily for 3 days
    • single dose on day 4
Study groups in NCT02616445
Study groupRoleWhat they receive
MAD StudyPlacebo comparatorNot described
Receives: Drug: UE2343; Drug: Placebo
Fed-FastedPlacebo comparatorNot described
Receives: Drug: Placebo; Drug: UE2343
CSFExperimentalNot described
Receives: Drug: UE2343

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to Day 17

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

    Measured: Day 1 and Day 8

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

    Measured: Day 1 and Day 8

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

    Measured: Day 1 and Day 8

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

    Measured: Day 1 and Day 8

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

    Measured: Day 4

Secondary outcomes (14)

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

    Measured: Day 1 and Day 10

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

    Measured: Day 1 and Day 10

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

    Measured: Day 1 and Day 10

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

    Measured: Day 1 and Day 10

  5. 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

    Measured: Day 1 and Day 10

  6. Assess PK Parameter Maximum Plasma Concentration (Cmax) of UE2343 in CSF compared to the Cmax value obtained in plasma

    Measured: Day 4

  7. Assess Pharmacodynamics (PD) Blood parameter Adrenocorticotropic hormone (ACTH) from baseline to end of study

    Measured: Days 1, 10, 11, 12, 13 and 17.

  8. Assess Pharmacodynamics (PD) Blood parameter Serum Cortisol from baseline to end of study

    Measured: Days 1, 10, 11, 12, 13 and 17.

  9. Assess Pharmacodynamics (PD) Blood parameter for Adrenal Androgens from baseline to end of study

    Measured: Days 1, 10, 11, 12, 13 and 17.

  10. Assess Pharmacodynamics (PD) Urine parameter Urinary Free Cortisol (UFF) from baseline to end of study

    Measured: Days 1, 10, 11 and 12

  11. Assess Pharmacodynamics (PD) Urine parameter Urinary Free Cortisone (UFE) from baseline to end of study

    Measured: Days 1, 10, 11 and 12

  12. Assess Pharmacodynamics (PD) Urine parameter 5α-tetrahydrocortisol (5αTHF) from baseline to end of study

    Measured: Days 1, 10, 11 and 12

  13. Assess Pharmacodynamics (PD) Urine parameter 5β-tetrahydrocortisol (5βTHF) from baseline to end of study

    Measured: Days 1, 10, 11 and 12

  14. Assess Pharmacodynamics (PD) Urine parameter tetrahydrocortisone (THE) from baseline to end of study

    Measured: Days 1, 10, 11 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionAug 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02616445
Sponsor's protocol ID
ACW0001
Status last verified
May 2017
First submitted
5 Nov 2015
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28012176

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing UE2343 in people with Healthy Volunteers, run by Actinogen Medical at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess Safety and Tolerability of UE2343 over 17 days including AEs, 12-lead ECGs, vital signs, Nerve conduction velocity, Labs. (time frame: Up to Day 17). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02616445, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.

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