Clinical trial

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

Name

TR01-XR-101

Description

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.

Trial arms

Trial start

2023-02-14

Estimated PCD

2024-03-01

Trial end

2024-03-01

Status

Recruiting

Phase

Early phase I

Treatment

TR-01-XRR (1)

Extended-release form

Arms:

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

Other names:

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

TR-01-XRR (2)

Extended-release form

Arms:

Part 1 Single Dose

Other names:

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

TR-01-XRR (3)

Extended-release form

Arms:

Part 1 Single Dose

Other names:

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

TR-01-XRS

Extended-release form

Arms:

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

Other names:

S-Idazoxan Extended Release Tablet

TR-01-XR

Extended-release form

Arms:

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

Other names:

Racemic Idazoxan HCL Extended Release Tablet

TR-01-IR

Active comparator

Arms:

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

Other names:

Idazoxan HCL Immediate Release Tablet

Placebo

Placebo comparator

Arms:

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

Other names:

Matching Placebo Tablet

Size

150

Primary endpoint

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

Through study completion up to 25 days after initial dose

Area under the plasma concentration-time curve (AUC)

Up to 120 hours after dose

Maximum plasma concentration (Cmax)

Up to 120 hours after dose

Time to maximum plasma concentration (Tmax)

Up to 120 hours after dose

Terminal elimination rate constant

Up to 120 hours after dose

Terminal elimination half-life (T1/2)

Up to 120 hours after dose

Apparent total clearance from plasma (CL/F)

Up to 120 hours after dose

Apparent volume of distribution (Vz/F)

Up to 120 hours after dose

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Part 1: Parallel group comparison, single dose level of 5 forms of the investigational study drug.\n\nPart 2: Parallel group comparison, single dose escalation (3 dose levels) of 4 forms investigational study drug and placebo.\n\nPart 3: Placebo controlled, multiple dose cross-over within 4 parallel group comparison.\n\nPart 4: Single-dose food effect cross-over.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Part 1: Open Label Part 2: Double-blind Placebo Controlled Part 3: Double-blind Placebo Controlled Part 4: Open Label', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

Updated at

2023-11-27

1 organization

5 products

1 indication

Organization

Terran Biosciences Australia

Product

Indication

Product

Product

Product

Product