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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Terran Biosciences Australia Pty Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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