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Trial record 2 of 3 for:    UE2343
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Phase I MAD, Fed-Fasted, CSF Study of UE2343 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02616445
Recruitment Status : Completed
First Posted : November 30, 2015
Last Update Posted : May 2, 2017
Sponsor:
Collaborators:
Novotech (Australia) Pty Limited
Linear Clinical Research
Information provided by (Responsible Party):
Actinogen Medical

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: UE2343 Drug: Placebo Phase 1

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : February 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: MAD Study Drug: UE2343
  • UE2343
  • 10mg, 20, 35mg
  • twice daily for 9 days

Drug: Placebo
  • 10mg, 20, 35mg
  • twice daily for 9 days
Placebo Comparator: Fed-Fasted Drug: Placebo
  • Cross-over study
  • single dose administered twice (on day 1 and day 8)
  • study duration 17 days

Drug: UE2343
  • Cross-over study
  • UE2343
  • single dose administered twice (on day 1 and day 8)
  • study duration 17 days
Experimental: CSF Drug: UE2343
  • UE2343
  • twice daily for 3 days
  • single dose on day 4


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616445


Locations
Australia, Western Australia
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Actinogen Medical
Novotech (Australia) Pty Limited
Linear Clinical Research
Investigators
Study Chair: Vincent Ruffles Actinogen Medical
Principal Investigator: Janakan Krishnarajah Linear Clinical Research Limited
More Information
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Publications of Results:

Responsible Party: Actinogen Medical
ClinicalTrials.gov Identifier: NCT02616445     History of Changes
Other Study ID Numbers: ACW0001
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Actinogen Medical:
Xanamem