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A Study of Idazoxan in Healthy Participants

NCT ID: NCT05727189

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-14

Study Completion Date

2024-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Part 1: Open Label Part 2: Double-blind Placebo Controlled Part 3: Double-blind Placebo Controlled Part 4: Open Label

Study Groups

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Part 1 Single Dose

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

Group Type EXPERIMENTAL

TR-01-XRR (1)

Intervention Type DRUG

Extended-release form

TR-01-XRR (2)

Intervention Type DRUG

Extended-release form

TR-01-XRR (3)

Intervention Type DRUG

Extended-release form

TR-01-XRS

Intervention Type DRUG

Extended-release form

TR-01-XR

Intervention Type DRUG

Extended-release form

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.

Group Type EXPERIMENTAL

TR-01-XRR (1)

Intervention Type DRUG

Extended-release form

TR-01-XRS

Intervention Type DRUG

Extended-release form

TR-01-XR

Intervention Type DRUG

Extended-release form

TR-01-IR

Intervention Type DRUG

Active comparator

Placebo

Intervention Type DRUG

Placebo comparator

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.

Group Type EXPERIMENTAL

TR-01-XRR (1)

Intervention Type DRUG

Extended-release form

TR-01-XRS

Intervention Type DRUG

Extended-release form

TR-01-XR

Intervention Type DRUG

Extended-release form

TR-01-IR

Intervention Type DRUG

Active comparator

Placebo

Intervention Type DRUG

Placebo comparator

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.

Group Type EXPERIMENTAL

TR-01-XRR (1)

Intervention Type DRUG

Extended-release form

Interventions

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TR-01-XRR (1)

Extended-release form

Intervention Type DRUG

TR-01-XRR (2)

Extended-release form

Intervention Type DRUG

TR-01-XRR (3)

Extended-release form

Intervention Type DRUG

TR-01-XRS

Extended-release form

Intervention Type DRUG

TR-01-XR

Extended-release form

Intervention Type DRUG

TR-01-IR

Active comparator

Intervention Type DRUG

Placebo

Placebo comparator

Intervention Type DRUG

Other Intervention Names

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R-Idazoxan HCL Extended Release (medium release rate) Tablet R-Idazoxan HCL Extended Release (faster release rate) Tablet R-Idazoxan HCL Extended Release (slower release rate) Tablet S-Idazoxan Extended Release Tablet Racemic Idazoxan HCL Extended Release Tablet Idazoxan HCL Immediate Release Tablet Matching Placebo Tablet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Terran Biosciences Australia Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Fishman, MD

Role: STUDY_DIRECTOR

Clinical Lead Consultant

Locations

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Scientia Clinical Research

Randwick, New South Wales, Australia

Site Status RECRUITING

CMAX Clinical Research

Adelaide, South Australia, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Terran Clinical

Role: CONTACT

[email protected]
+1 (646) 837-5687

Facility Contacts

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Susie Zaborszky

Role: primary

[email protected]
+61 2 9382 5896

Briohny Johnston

Role: primary

[email protected]
+61 8 7088 7943

Other Identifiers

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TR01-XR-101

Identifier Type: -

Identifier Source: org_study_id