A Study of Idazoxan in Healthy Participants
- 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.
- Short title
- A Study of Idazoxan in Healthy Participants
- 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
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-12-01
- First posted
- 2023-02-14
- Registry last updated
- 2026-03-18
- Primary completion date
- 2027-12-01
- Start date
- 2023-02-14
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Terran Biosciences Australia Pty Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05727189
- ClinicalTrials.gov ID
- NCT05727189
- Registry record
- Open registry record
- 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
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.
Area under the plasma concentration-time curve (AUC)
Timeframe: Up to 120 hours after dose
To evaluate drug exposure over specified measurement time frame
Maximum plasma concentration (Cmax)
Timeframe: Up to 120 hours after dose
To evaluate peak drug concentration achieved during specified measurement time frame
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
Terminal elimination rate constant
Timeframe: Up to 120 hours after dose
To evaluate rate of drug elimination
Terminal elimination half-life (T1/2)
Timeframe: Up to 120 hours after dose
To evaluate time over which drug concentration is decreased by half
Apparent total clearance from plasma (CL/F)
Timeframe: Up to 120 hours after dose
To evaluate rate of drug clearance
Apparent volume of distribution (Vz/F)
Timeframe: Up to 120 hours after dose
To evaluate extent of drug distribution in the body
Relative bioavailability (Frel)
Timeframe: Over 120 hours after dose
To compare single dose oral bioavailability in fed and fasted states
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- BMI between 18 and 32 kg/m2
- Medically healthy without clinically significant or relevant medical history
- 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
- Scientia Clinical ResearchRandwick, Australia
- CMAX Clinical ResearchAdelaide, Australia