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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02616445




Registration number
NCT02616445
Ethics application status
Date submitted
5/11/2015
Date registered
30/11/2015
Date last updated
2/05/2017

Titles & IDs
Public title
Phase I MAD, Fed-Fasted, CSF Study of UE2343 in Healthy Subjects
Scientific 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
Secondary ID [1] 0 0
ACW0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - UE2343
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - UE2343
Treatment: Drugs - UE2343

Placebo comparator: MAD Study -

Placebo comparator: Fed-Fasted -

Experimental: CSF -


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

Treatment: Drugs: Placebo
* 10mg, 20, 35mg
* twice daily for 9 days

Treatment: Drugs: Placebo
* Cross-over study
* single dose administered twice (on day 1 and day 8)
* study duration 17 days

Treatment: Drugs: UE2343
* Cross-over study
* UE2343
* single dose administered twice (on day 1 and day 8)
* study duration 17 days

Treatment: Drugs: UE2343
* UE2343
* twice daily for 3 days
* single dose on day 4
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess Safety and Tolerability of UE2343 over 17 days including AEs, 12-lead ECGs, vital signs, Nerve conduction velocity, Labs.
Timepoint [1] 0 0
Up to Day 17
Primary outcome [2] 0 0
Assess the Pharmacokinetic (PK) Plasma Parameter Maximum Plasma Concentration (Cmax) of UE2343 after a single dose
Timepoint [2] 0 0
Day 1 and Day 8
Primary outcome [3] 0 0
Assess the Pharmacokinetic (PK) Plasma Parameter Time to Cmax (Tmax) of UE2343 after a single dose
Timepoint [3] 0 0
Day 1 and Day 8
Primary outcome [4] 0 0
Assess the Pharmacokinetic (PK) Plasma Parameter Area Under the Curve (AUC) of UE2343 after a single dose
Timepoint [4] 0 0
Day 1 and Day 8
Primary outcome [5] 0 0
Assess the Pharmacokinetic (PK) Plasma Parameter Terminal Elimination Half Life (t½) of UE2343 after a single dose
Timepoint [5] 0 0
Day 1 and Day 8
Primary outcome [6] 0 0
Assess PK Parameter Maximum Plasma Concentration (Cmax) of UE2343 in CSF
Timepoint [6] 0 0
Day 4
Secondary outcome [1] 0 0
Assess Pharmacokinetics (PK) Plasma parameter Maximum Plasma Concentration (Cmax) from time of dosing to 12 hours
Timepoint [1] 0 0
Day 1 and Day 10
Secondary outcome [2] 0 0
Assess Pharmacokinetics (PK) Plasma parameter Time to Cmax (Tmax) from time of dosing to 12 hours
Timepoint [2] 0 0
Day 1 and Day 10
Secondary outcome [3] 0 0
Assess Pharmacokinetics (PK) Plasma parameter Area Under the Curve (AUC) from time of dosing to 12 hours
Timepoint [3] 0 0
Day 1 and Day 10
Secondary outcome [4] 0 0
Assess Pharmacokinetics (PK) Plasma parameter Terminal Elimination Half Life (t½) from time of dosing to 12 hours
Timepoint [4] 0 0
Day 1 and Day 10
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Day 1 and Day 10
Secondary outcome [6] 0 0
Assess PK Parameter Maximum Plasma Concentration (Cmax) of UE2343 in CSF compared to the Cmax value obtained in plasma
Timepoint [6] 0 0
Day 4
Secondary outcome [7] 0 0
Assess Pharmacodynamics (PD) Blood parameter Adrenocorticotropic hormone (ACTH) from baseline to end of study
Timepoint [7] 0 0
Days 1, 10, 11, 12, 13 and 17.
Secondary outcome [8] 0 0
Assess Pharmacodynamics (PD) Blood parameter Serum Cortisol from baseline to end of study
Timepoint [8] 0 0
Days 1, 10, 11, 12, 13 and 17.
Secondary outcome [9] 0 0
Assess Pharmacodynamics (PD) Blood parameter for Adrenal Androgens from baseline to end of study
Timepoint [9] 0 0
Days 1, 10, 11, 12, 13 and 17.
Secondary outcome [10] 0 0
Assess Pharmacodynamics (PD) Urine parameter Urinary Free Cortisol (UFF) from baseline to end of study
Timepoint [10] 0 0
Days 1, 10, 11 and 12
Secondary outcome [11] 0 0
Assess Pharmacodynamics (PD) Urine parameter Urinary Free Cortisone (UFE) from baseline to end of study
Timepoint [11] 0 0
Days 1, 10, 11 and 12
Secondary outcome [12] 0 0
Assess Pharmacodynamics (PD) Urine parameter 5a-tetrahydrocortisol (5aTHF) from baseline to end of study
Timepoint [12] 0 0
Days 1, 10, 11 and 12
Secondary outcome [13] 0 0
Assess Pharmacodynamics (PD) Urine parameter 5ß-tetrahydrocortisol (5ßTHF) from baseline to end of study
Timepoint [13] 0 0
Days 1, 10, 11 and 12
Secondary outcome [14] 0 0
Assess Pharmacodynamics (PD) Urine parameter tetrahydrocortisone (THE) from baseline to end of study
Timepoint [14] 0 0
Days 1, 10, 11 and 12

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Abnormal medical history, including history of dementia
* No significant allergic reactions
* No prior drug or alcohol abuse
* Use of regular prescribed medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Actinogen Medical
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Linear Clinical Research
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02616445
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Vincent Ruffles
Address 0 0
Actinogen Medical
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02616445