A Study of Idazoxan in Healthy Participants

Phase 1Active Not RecruitingNCT05727189

Terran Biosciences Australia Pty Ltd150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Healthy

Interventions

TR-01-XRR (1)DRUG

Extended-release form

TR-01-XRR (2)DRUG

Extended-release form

TR-01-XRR (3)DRUG

Extended-release form

TR-01-XRS

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Scientia Clinical Research

Randwick, New South Wales, Australia

CMAX Clinical Research

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

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.

Time frame: 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