Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05727189




Registration number
NCT05727189
Ethics application status
Date submitted
25/01/2023
Date registered
14/02/2023
Date last updated
27/11/2023

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
Four-part study of the safety, tolerability and pharmacokinetics of 3 forms of TR-01-XRR, 1
form of TR-01-XRS, and 1 form of TR-01-XR in healthy adults.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05727189
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
info@terranbiosciences.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05727189