A Study of Idazoxan in Healthy Participants

March 16, 2026 updated by: Terran Biosciences Australia Pty Ltd

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Scientia Clinical Research
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • CMAX Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • BMI between 18 and 32 kg/m2
  • Medically healthy without clinically significant or relevant medical history

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1 Single Dose
Parallel group comparison, single dose level of 5 forms of the investigational study drug.
Drug: TR-01-XRR (1)
Extended-release form
Other Names:
  • R-Idazoxan HCL Extended Release (medium release rate) Tablet
Drug: TR-01-XRR (2)
Extended-release form
Other Names:
  • R-Idazoxan HCL Extended Release (faster release rate) Tablet
Drug: TR-01-XRR (3)
Extended-release form
Other Names:
  • R-Idazoxan HCL Extended Release (slower release rate) Tablet
Drug: TR-01-XRS
Extended-release form
Other Names:
  • S-Idazoxan Extended Release Tablet
Drug: TR-01-XR
Extended-release form
Other Names:
  • Racemic Idazoxan HCL Extended Release Tablet
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.
Drug: Placebo
Placebo comparator
Other Names:
  • Matching Placebo Tablet
Drug: TR-01-XRR (1)
Extended-release form
Other Names:
  • R-Idazoxan HCL Extended Release (medium release rate) Tablet
Drug: TR-01-XRS
Extended-release form
Other Names:
  • S-Idazoxan Extended Release Tablet
Drug: TR-01-XR
Extended-release form
Other Names:
  • Racemic Idazoxan HCL Extended Release Tablet
Drug: TR-01-IR
Active comparator
Other Names:
  • Idazoxan HCL Immediate Release Tablet
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.
Drug: TR-01-XRR (1)
Extended-release form
Other Names:
  • R-Idazoxan HCL Extended Release (medium release rate) Tablet
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.
Drug: Placebo
Placebo comparator
Other Names:
  • Matching Placebo Tablet
Drug: TR-01-XRR (1)
Extended-release form
Other Names:
  • R-Idazoxan HCL Extended Release (medium release rate) Tablet
Drug: TR-01-XRS
Extended-release form
Other Names:
  • S-Idazoxan Extended Release Tablet
Drug: TR-01-XR
Extended-release form
Other Names:
  • Racemic Idazoxan HCL Extended Release Tablet
Drug: TR-01-IR
Active comparator
Other Names:
  • Idazoxan HCL Immediate Release Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events based on clinical observation and participant report
Time Frame: Through study completion up to 25 days after initial dose
Clinically observed adverse events include findings from physical examination, vital sign, ECG and laboratory assessments (hematological and clinical chemistry laboratory panels). Participant report includes any side effect reported by a participant during the study.
Through study completion up to 25 days after initial dose
Area under the plasma concentration-time curve (AUC)
Time Frame: Up to 120 hours after dose
To evaluate drug exposure over specified measurement time frame
Up to 120 hours after dose
Maximum plasma concentration (Cmax)
Time Frame: Up to 120 hours after dose
To evaluate peak drug concentration achieved during specified measurement time frame
Up to 120 hours after dose
Time to maximum plasma concentration (Tmax)
Time Frame: Up to 120 hours after dose
To evaluate time to achieve peak concentration during specified measurement time frame
Up to 120 hours after dose
Terminal elimination rate constant
Time Frame: Up to 120 hours after dose
To evaluate rate of drug elimination
Up to 120 hours after dose
Terminal elimination half-life (T1/2)
Time Frame: Up to 120 hours after dose
To evaluate time over which drug concentration is decreased by half
Up to 120 hours after dose
Apparent total clearance from plasma (CL/F)
Time Frame: Up to 120 hours after dose
To evaluate rate of drug clearance
Up to 120 hours after dose
Apparent volume of distribution (Vz/F)
Time Frame: Up to 120 hours after dose
To evaluate extent of drug distribution in the body
Up to 120 hours after dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative bioavailability (Frel)
Time Frame: Over 120 hours after dose
To compare single dose oral bioavailability in fed and fasted states
Over 120 hours after dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Terran Biosciences Australia Pty Ltd

Investigators

  • Study Director: Robert Fishman, MD, Clinical Lead Consultant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

February 3, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR01-XR-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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