A Study of Idazoxan in Healthy Participants

NCT05727189 | Active Not Recruiting Phase 1

• 1 other identifier: TR01-XR-101
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• Number of participants with treatment-related adverse events based on clinical observation and participant report

  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)

  To evaluate drug exposure over specified measurement time frame

  Up to 120 hours after dose

• Maximum plasma concentration (Cmax)

  To evaluate peak drug concentration achieved during specified measurement time frame

  Up to 120 hours after dose

• Time to maximum plasma concentration (Tmax)

  To evaluate time to achieve peak concentration during specified measurement time frame

  Up to 120 hours after dose

• Terminal elimination rate constant

  To evaluate rate of drug elimination

  Up to 120 hours after dose

• Terminal elimination half-life (T1/2)

  To evaluate time over which drug concentration is decreased by half

  Up to 120 hours after dose

• Apparent total clearance from plasma (CL/F)

  To evaluate rate of drug clearance

  Up to 120 hours after dose

• Apparent volume of distribution (Vz/F)

  To evaluate extent of drug distribution in the body

  Up to 120 hours after dose

Secondary Outcomes (1)

• Relative bioavailability (Frel)

  Over 120 hours after dose

Study Arms (4)

Part 1 Single Dose

EXPERIMENTAL

Parallel group comparison, single dose level of 5 forms of the investigational study drug.

Drug: TR-01-XRR (1); Drug: TR-01-XRR (2); Drug: TR-01-XRR (3); Drug: TR-01-XRS; Drug: TR-01-XR

Part 2: Single escalating doses

EXPERIMENTAL

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: TR-01-XRR (1); Drug: TR-01-XRS; Drug: TR-01-XR; Drug: TR-01-IR; Drug: Placebo

Part 3: Multiple Dose

EXPERIMENTAL

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: TR-01-XRR (1); Drug: TR-01-XRS; Drug: TR-01-XR; Drug: TR-01-IR; Drug: Placebo

Part 4: Food Effects

EXPERIMENTAL

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)

Interventions

TR-01-XRR (1) DRUG

Extended-release form

Also known as: R-Idazoxan HCL Extended Release (medium release rate) Tablet

Part 1 Single Dose; Part 2: Single escalating doses; Part 3: Multiple Dose; Part 4: Food Effects

TR-01-XRR (2) DRUG

Extended-release form

Also known as: R-Idazoxan HCL Extended Release (faster release rate) Tablet

Part 1 Single Dose

TR-01-XRR (3) DRUG

Extended-release form

Also known as: R-Idazoxan HCL Extended Release (slower release rate) Tablet

Part 1 Single Dose

TR-01-XRS DRUG

Extended-release form

Also known as: S-Idazoxan Extended Release Tablet

Part 1 Single Dose; Part 2: Single escalating doses; Part 3: Multiple Dose

TR-01-XR DRUG

Extended-release form

Also known as: Racemic Idazoxan HCL Extended Release Tablet

Part 1 Single Dose; Part 2: Single escalating doses; Part 3: Multiple Dose

TR-01-IR DRUG

Active comparator

Also known as: Idazoxan HCL Immediate Release Tablet

Part 2: Single escalating doses; Part 3: Multiple Dose

Placebo DRUG

Placebo comparator

Also known as: Matching Placebo Tablet

Part 2: Single escalating doses; Part 3: Multiple Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Terran Biosciences Australia Pty Ltd: lead

Study Sites (2)

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

Location

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Robert Fishman, MD

  Clinical Lead Consultant

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part 1: Open Label Part 2: Double-blind Placebo Controlled Part 3: Double-blind Placebo Controlled Part 4: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: Parallel group comparison, single dose level of 5 forms of the investigational study drug. Part 2: Parallel group comparison, single dose escalation (3 dose levels) of 4 forms investigational study drug and placebo. Part 3: Placebo controlled, multiple dose cross-over within 4 parallel group comparison. Part 4: Single-dose food effect cross-over.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 14, 2023
• Study Start: February 14, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)