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A Study of Idazoxan in Healthy Participants

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ClinicalTrials.gov Identifier: NCT05727189
Recruitment Status : Recruiting
First Posted : February 14, 2023
Last Update Posted : November 27, 2023
Sponsor:
Information provided by (Responsible Party):
Terran Biosciences Australia Pty Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: TR-01-XRR (1) Drug: TR-01-XRR (2) Drug: TR-01-XRR (3) Drug: TR-01-XRS Drug: TR-01-XR Drug: TR-01-IR Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.
Masking: Double (Participant, Investigator)
Masking Description: Part 1: Open Label Part 2: Double-blind Placebo Controlled Part 3: Double-blind Placebo Controlled Part 4: Open Label
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 14, 2023
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024
Arms and Interventions
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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 Name: R-Idazoxan HCL Extended Release (medium release rate) Tablet

Drug: TR-01-XRR (2)
Extended-release form
Other Name: R-Idazoxan HCL Extended Release (faster release rate) Tablet

Drug: TR-01-XRR (3)
Extended-release form
Other Name: R-Idazoxan HCL Extended Release (slower release rate) Tablet

Drug: TR-01-XRS
Extended-release form
Other Name: S-Idazoxan Extended Release Tablet

Drug: TR-01-XR
Extended-release form
Other Name: Racemic Idazoxan HCL Extended Release 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: TR-01-XRR (1)
Extended-release form
Other Name: R-Idazoxan HCL Extended Release (medium release rate) Tablet

Drug: TR-01-XRS
Extended-release form
Other Name: S-Idazoxan Extended Release Tablet

Drug: TR-01-XR
Extended-release form
Other Name: Racemic Idazoxan HCL Extended Release Tablet

Drug: TR-01-IR
Active comparator
Other Name: Idazoxan HCL Immediate Release Tablet

Drug: Placebo
Placebo comparator
Other Name: Matching Placebo 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: TR-01-XRR (1)
Extended-release form
Other Name: R-Idazoxan HCL Extended Release (medium release rate) Tablet

Drug: TR-01-XRS
Extended-release form
Other Name: S-Idazoxan Extended Release Tablet

Drug: TR-01-XR
Extended-release form
Other Name: Racemic Idazoxan HCL Extended Release Tablet

Drug: TR-01-IR
Active comparator
Other Name: Idazoxan HCL Immediate Release Tablet

Drug: Placebo
Placebo comparator
Other Name: Matching Placebo 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 Name: R-Idazoxan HCL Extended Release (medium release rate) Tablet


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Relative bioavailability (Frel) [ Time Frame: Over 120 hours after dose ]
    To compare single dose oral bioavailability in fed and fasted states


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05727189


Contacts
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Contact: Terran Clinical +1 (646) 837-5687 info@terranbiosciences.com

Locations
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Australia, New South Wales
Scientia Clinical Research Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Susie Zaborszky    +61 2 9382 5896    susie.zaborszky@scientiaclinicalresearch.com.au   
Principal Investigator: Christopher Argent, MD         
Australia, South Australia
CMAX Clinical Research Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Briohny Johnston    +61 8 7088 7943    Briohny.Johnston@cmax.com.au   
Principal Investigator: Jonathan Newchurch, MD         
Sponsors and Collaborators
Terran Biosciences Australia Pty Ltd
Investigators
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Study Director: Robert Fishman, MD Clinical Lead Consultant
More Information
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Responsible Party: Terran Biosciences Australia Pty Ltd
ClinicalTrials.gov Identifier: NCT05727189    
Other Study ID Numbers: TR01-XR-101
First Posted: February 14, 2023    Key Record Dates
Last Update Posted: November 27, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Idazoxan
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs