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NCT Number: NCT05727189

A Study of Idazoxan 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Scientia Clinical Research, Randwick, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TR-01-XRR (1)

Drug

Extended-release form

Other names: R-Idazoxan HCL Extended Release (medium release rate) Tablet

TR-01-XRR (2)

Drug

Extended-release form

Other names: R-Idazoxan HCL Extended Release (faster release rate) Tablet

TR-01-XRR (3)

Drug

Extended-release form

Other names: R-Idazoxan HCL Extended Release (slower release rate) Tablet

TR-01-XRS

Drug

Extended-release form

Other names: S-Idazoxan Extended Release Tablet

TR-01-XR

Drug

Extended-release form

Other names: Racemic Idazoxan HCL Extended Release Tablet

TR-01-IR

Drug

Active comparator

Other names: Idazoxan HCL Immediate Release Tablet

Placebo

Drug

Placebo comparator

Other names: Matching Placebo Tablet

Primary outcomes

  1. 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.

  2. 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

  3. Maximum plasma concentration (Cmax)

    Time frame: Up to 120 hours after dose

    To evaluate peak drug concentration achieved during specified measurement time frame

  4. 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

  5. Terminal elimination rate constant

    Time frame: Up to 120 hours after dose

    To evaluate rate of drug elimination

  6. 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

  7. Apparent total clearance from plasma (CL/F)

    Time frame: Up to 120 hours after dose

    To evaluate rate of drug clearance

  8. Apparent volume of distribution (Vz/F)

    Time frame: Up to 120 hours after dose

    To evaluate extent of drug distribution in the body

Secondary outcomes

  1. Relative bioavailability (Frel)

    Time frame: Over 120 hours after dose

    To compare single dose oral bioavailability in fed and fasted states

Sponsors and collaborators

Lead sponsor

Terran Biosciences Australia Pty Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 14, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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