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Completed

NCT Number: NCT02616445

Phase I MAD, Fed-Fasted, CSF Study 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UE2343

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

Placebo

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

Primary outcomes

  1. 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

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

    Time frame: Day 1 and Day 8

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

    Time frame: Day 1 and Day 8

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

    Time frame: Day 1 and Day 8

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

    Time frame: Day 1 and Day 8

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

    Time frame: Day 4

Secondary outcomes

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

    Time frame: Day 1 and Day 10

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

    Time frame: Day 1 and Day 10

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

    Time frame: Day 1 and Day 10

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

    Time frame: 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

    Time frame: 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

    Time frame: Day 4

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

    Time frame: Days 1, 10, 11, 12, 13 and 17.

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

    Time frame: Days 1, 10, 11, 12, 13 and 17.

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

    Time frame: Days 1, 10, 11, 12, 13 and 17.

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

    Time frame: Days 1, 10, 11 and 12

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

    Time frame: Days 1, 10, 11 and 12

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

    Time frame: Days 1, 10, 11 and 12

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

    Time frame: Days 1, 10, 11 and 12

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

    Time frame: Days 1, 10, 11 and 12

Sponsors and collaborators

Lead sponsor

Actinogen Medical

Industry

Collaborators

  • Linear Clinical Research
  • Novotech (Australia) Pty Limited

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 30, 2015
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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