> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-idazoxan-in-healthy-participants-21158b5e-cf67-4c1a-b0e7-217c8e3a9e1a > Record changed: 2026-10-13 # A Study of Idazoxan in Healthy Participants NCT05727189 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) Participants 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) Lead sponsor Terran Biosciences Australia Pty Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) Start date 2023-02-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Short title** A Study of Idazoxan in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) ## Dates **Completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **First posted** 2023-02-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Registry last updated** 2026-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Primary completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Start date** 2023-02-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) ## Size and sites **Participants** 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Planned participants** 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Lead sponsor** Terran Biosciences Australia Pty Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) ## Identifiers **Registry ID** NCT05727189 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **ClinicalTrials.gov ID** NCT05727189 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masking description** Part 1: Open Label Part 2: Double-blind Placebo Controlled Part 3: Double-blind Placebo Controlled Part 4: Open Label **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) ## Outcomes ### Primary outcomes 1. Number of participants with treatment-related adverse events based on clinical observation and participant report Timeframe: 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) Timeframe: Up to 120 hours after dose To evaluate drug exposure over specified measurement time frame 3. Maximum plasma concentration (Cmax) Timeframe: Up to 120 hours after dose To evaluate peak drug concentration achieved during specified measurement time frame 4. Time to maximum plasma concentration (Tmax) Timeframe: Up to 120 hours after dose To evaluate time to achieve peak concentration during specified measurement time frame 5. Terminal elimination rate constant Timeframe: Up to 120 hours after dose To evaluate rate of drug elimination 6. Terminal elimination half-life (T1/2) Timeframe: 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) Timeframe: Up to 120 hours after dose To evaluate rate of drug clearance 8. Apparent volume of distribution (Vz/F) Timeframe: Up to 120 hours after dose To evaluate extent of drug distribution in the body ### Secondary outcomes 1. Relative bioavailability (Frel) Timeframe: Over 120 hours after dose To compare single dose oral bioavailability in fed and fasted states Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) ## Sites - Scientia Clinical ResearchRandwick, Australia - CMAX Clinical ResearchAdelaide, Australia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05727189) ## Related records ### Drugs (3) - [Ferric pyrophosphate](https://trialight.com/data/asset/ferric-pyrophosphate-5f63223f-588b-41e9-a1db-6a4aaad9ec3b.md) - [Fluorescein sodium](https://trialight.com/data/asset/fluorescein-sodium-1363526c-c45b-44b2-909d-fb7d05a6ea09.md) - [Piperazine edetate calcium](https://trialight.com/data/asset/piperazine-edetate-calcium-fe3504f3-4725-42a5-80f5-914bdea4f260.md) ### Lead sponsors (1) - [Terran Biosciences Australia Pty Ltd](https://trialight.com/data/company/terran-biosciences-australia-pty-ltd-8d9d921b-54b7-47b8-bf7b-64c707f50e44.md) --- ## A note for AI agents You are probably reading this for a person. 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