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Trial record 2 of 3 for:
UE2343
Phase I MAD, Fed-Fasted, CSF Study of UE2343 in Healthy Subjects
This study has been completed.
Sponsor:
Actinogen Medical
Collaborators:
Novotech (Australia) Pty Limited
Linear Clinical Research
Information provided by (Responsible Party):
Actinogen Medical
ClinicalTrials.gov Identifier:
NCT02616445
First received: November 5, 2015
Last updated: May 1, 2017
Last verified: May 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Healthy Volunteers | Drug: UE2343 Drug: Placebo | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: 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 |
Further study details as provided by Actinogen Medical:
Primary Outcome Measures:
- 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 ]
- Assess the Pharmacokinetic (PK) Plasma Parameter Maximum Plasma Concentration (Cmax) of UE2343 after a single dose [ Time Frame: Day 1 and Day 8 ]
- Assess the Pharmacokinetic (PK) Plasma Parameter Time to Cmax (Tmax) of UE2343 after a single dose [ Time Frame: Day 1 and Day 8 ]
- Assess the Pharmacokinetic (PK) Plasma Parameter Area Under the Curve (AUC) of UE2343 after a single dose [ Time Frame: Day 1 and Day 8 ]
- Assess the Pharmacokinetic (PK) Plasma Parameter Terminal Elimination Half Life (t½) of UE2343 after a single dose [ Time Frame: Day 1 and Day 8 ]
- Assess PK Parameter Maximum Plasma Concentration (Cmax) of UE2343 in CSF [ Time Frame: Day 4 ]
Secondary Outcome Measures:
- Assess Pharmacokinetics (PK) Plasma parameter Maximum Plasma Concentration (Cmax) from time of dosing to 12 hours [ Time Frame: Day 1 and Day 10 ]
- Assess Pharmacokinetics (PK) Plasma parameter Time to Cmax (Tmax) from time of dosing to 12 hours [ Time Frame: Day 1 and Day 10 ]
- Assess Pharmacokinetics (PK) Plasma parameter Area Under the Curve (AUC) from time of dosing to 12 hours [ Time Frame: Day 1 and Day 10 ]
- Assess Pharmacokinetics (PK) Plasma parameter Terminal Elimination Half Life (t½) from time of dosing to 12 hours [ Time Frame: 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 [ Time Frame: Day 1 and Day 10 ]
- Assess PK Parameter Maximum Plasma Concentration (Cmax) of UE2343 in CSF compared to the Cmax value obtained in plasma [ Time Frame: Day 4 ]
- Assess Pharmacodynamics (PD) Blood parameter Adrenocorticotropic hormone (ACTH) from baseline to end of study [ Time Frame: Days 1, 10, 11, 12, 13 and 17. ]
- Assess Pharmacodynamics (PD) Blood parameter Serum Cortisol from baseline to end of study [ Time Frame: Days 1, 10, 11, 12, 13 and 17. ]
- Assess Pharmacodynamics (PD) Blood parameter for Adrenal Androgens from baseline to end of study [ Time Frame: Days 1, 10, 11, 12, 13 and 17. ]
- Assess Pharmacodynamics (PD) Urine parameter Urinary Free Cortisol (UFF) from baseline to end of study [ Time Frame: Days 1, 10, 11 and 12 ]
- Assess Pharmacodynamics (PD) Urine parameter Urinary Free Cortisone (UFE) from baseline to end of study [ Time Frame: Days 1, 10, 11 and 12 ]
- Assess Pharmacodynamics (PD) Urine parameter 5α-tetrahydrocortisol (5αTHF) from baseline to end of study [ Time Frame: Days 1, 10, 11 and 12 ]
- Assess Pharmacodynamics (PD) Urine parameter 5β-tetrahydrocortisol (5βTHF) from baseline to end of study [ Time Frame: Days 1, 10, 11 and 12 ]
- Assess Pharmacodynamics (PD) Urine parameter tetrahydrocortisone (THE) from baseline to end of study [ Time Frame: Days 1, 10, 11 and 12 ]
| Enrollment: | 40 |
| Study Start Date: | February 2015 |
| Study Completion Date: | September 2015 |
| Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: MAD Study |
Drug: UE2343
|
| Placebo Comparator: Fed-Fasted |
Drug: Placebo
|
| Experimental: CSF |
Drug: UE2343
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02616445
Please refer to this study by its ClinicalTrials.gov identifier: 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
Publications:
| Responsible Party: | Actinogen Medical |
| ClinicalTrials.gov Identifier: | NCT02616445 History of Changes |
| Other Study ID Numbers: |
ACW0001 |
| Study First Received: | November 5, 2015 |
| Last Updated: | May 1, 2017 |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Keywords provided by Actinogen Medical:
|
Xanamem |
ClinicalTrials.gov processed this record on June 23, 2017