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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05727189




Registration number
NCT05727189
Ethics application status
Date submitted
25/01/2023
Date registered
14/02/2023

Titles & IDs
Public title
A Study of Idazoxan in Healthy Participants
Scientific title
A Phase 1 Safety, Tolerability and Pharmacokinetic Study of R-Idazoxan HCl Extended-Release (TR-01-XRR), S-Idazoxan HCl Extended-Release (TR-01-XRS) and Racemic Idazoxan HCl Extended-Release (TR-01-XR) in Healthy Participants
Secondary ID [1] 0 0
TR01-XR-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TR-01-XRR (1)
Treatment: Drugs - TR-01-XRR (2)
Treatment: Drugs - TR-01-XRR (3)
Treatment: Drugs - TR-01-XRS
Treatment: Drugs - TR-01-XR
Treatment: Drugs - TR-01-IR
Treatment: Drugs - Placebo

Experimental: Part 1 Single Dose - Parallel group comparison, single dose level of 5 forms of the investigational study drug.

Experimental: Part 2: Single escalating doses - Parallel group comparison, single p.o. dose escalation (3 dose levels) of 4 forms investigational study drug and placebo administered to two sequential cohorts. Dose Level 1 will be administered to the first cohort. Dose Levels 2 and 3 will be administered to a subsequent cohort. Dose levels in this cohort are separated by a 7-day washout period. Doses to be determined by review of data from Part 1.

Experimental: Part 3: Multiple Dose - Parallel group comparison of 4 active treatments dosed p.o. x 4 days. Each active is dosed in a 2-period placebo-controlled crossover separated by a 5-day washout. Doses to be determined by review of data from Part 2.

Experimental: Part 4: Food Effects - Two-period single p.o. dose fasted/fed crossover separated by 5-day washout period. Dose to be determined by review of data from Part 2.


Treatment: Drugs: TR-01-XRR (1)
Extended-release form

Treatment: Drugs: TR-01-XRR (2)
Extended-release form

Treatment: Drugs: TR-01-XRR (3)
Extended-release form

Treatment: Drugs: TR-01-XRS
Extended-release form

Treatment: Drugs: TR-01-XR
Extended-release form

Treatment: Drugs: TR-01-IR
Active comparator

Treatment: Drugs: Placebo
Placebo comparator
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-related adverse events based on clinical observation and participant report
Timepoint [1] 0 0
Through study completion up to 25 days after initial dose
Primary outcome [2] 0 0
Area under the plasma concentration-time curve (AUC)
Timepoint [2] 0 0
Up to 120 hours after dose
Primary outcome [3] 0 0
Maximum plasma concentration (Cmax)
Timepoint [3] 0 0
Up to 120 hours after dose
Primary outcome [4] 0 0
Time to maximum plasma concentration (Tmax)
Timepoint [4] 0 0
Up to 120 hours after dose
Primary outcome [5] 0 0
Terminal elimination rate constant
Timepoint [5] 0 0
Up to 120 hours after dose
Primary outcome [6] 0 0
Terminal elimination half-life (T1/2)
Timepoint [6] 0 0
Up to 120 hours after dose
Primary outcome [7] 0 0
Apparent total clearance from plasma (CL/F)
Timepoint [7] 0 0
Up to 120 hours after dose
Primary outcome [8] 0 0
Apparent volume of distribution (Vz/F)
Timepoint [8] 0 0
Up to 120 hours after dose
Secondary outcome [1] 0 0
Relative bioavailability (Frel)
Timepoint [1] 0 0
Over 120 hours after dose

Eligibility
Key inclusion criteria
* BMI between 18 and 32 kg/m2
* Medically healthy without clinically significant or relevant medical history
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Evidence of recurrent disease, physical illness or medical condition that could affect action, absorption or disposition of investigational products
* Use of any prescription or over-the-counter medication that cannot be discontinued for the duration of the study
* Impaired renal function
* Cardiac abnormalities
* Positive HIV, HBsAg or HCV
* Positive test for alcohol, drugs of abuse or cotinine

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
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [2] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Terran Biosciences Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Fishman, MD
Address 0 0
Clinical Lead Consultant
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Terran Clinical
Address 0 0
Country 0 0
Phone 0 0
+1 (646) 837-5687
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05727189