Testing Idazoxan in Healthy Adults
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
This study is testing how safe and well the body handles different forms of a new treatment in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Terran Biosciences Australia Pty Ltd Industry-sponsored |
| Locations | 2 sites (Randwick, New South Wales and 1 other locations) |
| Trial ID | NCT05727189 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and pharmacokinetics of three forms of TR-01-XRR, one form of TR-01-XRS, and one form of TR-01-XR in healthy adult participants. It is structured as a four-part interventional study to assess how these investigational products are processed in the body. Participants will be closely monitored for any adverse effects and how well their bodies absorb and metabolize the treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with a BMI between 18 and 32 kg/m2.
Not a fit: Patients with significant medical conditions, those on disallowed medications, or with a history of substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and pharmacokinetics of Idazoxan, potentially leading to its use in future therapeutic applications.
How similar studies have performed: While this study focuses on a specific investigational product, similar studies assessing the safety and pharmacokinetics of new drugs in healthy populations have shown success in the past.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Randwick, New South Wales and 1 other locations
- Scientia Clinical Research — Randwick, New South Wales, Australia (Recruiting)
- CMAX Clinical Research — Adelaide, South Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Terran Clinical
- Email: info@terranbiosciences.com
- Phone: +1 (646) 837-5687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.