A Study of Idazoxan in Healthy Participants
Phase 1
Recruiting
- Conditions
- Healthy
- Interventions
- Drug: TR-01-XRR (1)Drug: TR-01-XRR (2)Drug: TR-01-XRR (3)Drug: TR-01-XRSDrug: Placebo
- Registration Number
- NCT05727189
- Lead Sponsor
- Terran Biosciences Australia Pty Ltd
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 Single Dose TR-01-XR Parallel group comparison, single dose level of 5 forms of the investigational study drug. Part 1 Single Dose TR-01-XRS Parallel group comparison, single dose level of 5 forms of the investigational study drug. Part 1 Single Dose TR-01-XRR (3) Parallel group comparison, single dose level of 5 forms of the investigational study drug. Part 1 Single Dose TR-01-XRR (2) Parallel group comparison, single dose level of 5 forms of the investigational study drug. Part 2: Single escalating doses TR-01-XRR (1) Parallel group comparison, single p.o. dose escalation (3 dose levels) of 4 forms investigational study drug and placebo administered to two sequential cohorts. Dose Level 1 will be administered to the first cohort. Dose Levels 2 and 3 will be administered to a subsequent cohort. Dose levels in this cohort are separated by a 7-day washout period. Doses to be determined by review of data from Part 1. Part 1 Single Dose TR-01-XRR (1) Parallel group comparison, single dose level of 5 forms of the investigational study drug. Part 3: Multiple Dose TR-01-XR Parallel group comparison of 4 active treatments dosed p.o. x 4 days. Each active is dosed in a 2-period placebo-controlled crossover separated by a 5-day washout. Doses to be determined by review of data from Part 2. Part 2: Single escalating doses TR-01-XRS Parallel group comparison, single p.o. dose escalation (3 dose levels) of 4 forms investigational study drug and placebo administered to two sequential cohorts. Dose Level 1 will be administered to the first cohort. Dose Levels 2 and 3 will be administered to a subsequent cohort. Dose levels in this cohort are separated by a 7-day washout period. Doses to be determined by review of data from Part 1. Part 2: Single escalating doses Placebo Parallel group comparison, single p.o. dose escalation (3 dose levels) of 4 forms investigational study drug and placebo administered to two sequential cohorts. Dose Level 1 will be administered to the first cohort. Dose Levels 2 and 3 will be administered to a subsequent cohort. Dose levels in this cohort are separated by a 7-day washout period. Doses to be determined by review of data from Part 1. Part 4: Food Effects TR-01-XRR (1) Two-period single p.o. dose fasted/fed crossover separated by 5-day washout period. Dose to be determined by review of data from Part 2. Part 3: Multiple Dose TR-01-XRR (1) Parallel group comparison of 4 active treatments dosed p.o. x 4 days. Each active is dosed in a 2-period placebo-controlled crossover separated by a 5-day washout. Doses to be determined by review of data from Part 2. Part 3: Multiple Dose TR-01-XRS Parallel group comparison of 4 active treatments dosed p.o. x 4 days. Each active is dosed in a 2-period placebo-controlled crossover separated by a 5-day washout. Doses to be determined by review of data from Part 2. Part 3: Multiple Dose Placebo Parallel group comparison of 4 active treatments dosed p.o. x 4 days. Each active is dosed in a 2-period placebo-controlled crossover separated by a 5-day washout. Doses to be determined by review of data from Part 2. Part 2: Single escalating doses TR-01-XR Parallel group comparison, single p.o. dose escalation (3 dose levels) of 4 forms investigational study drug and placebo administered to two sequential cohorts. Dose Level 1 will be administered to the first cohort. Dose Levels 2 and 3 will be administered to a subsequent cohort. Dose levels in this cohort are separated by a 7-day washout period. Doses to be determined by review of data from Part 1. Part 2: Single escalating doses TR-01-IR Parallel group comparison, single p.o. dose escalation (3 dose levels) of 4 forms investigational study drug and placebo administered to two sequential cohorts. Dose Level 1 will be administered to the first cohort. Dose Levels 2 and 3 will be administered to a subsequent cohort. Dose levels in this cohort are separated by a 7-day washout period. Doses to be determined by review of data from Part 1. Part 3: Multiple Dose TR-01-IR Parallel group comparison of 4 active treatments dosed p.o. x 4 days. Each active is dosed in a 2-period placebo-controlled crossover separated by a 5-day washout. Doses to be determined by review of data from Part 2.
- Primary Outcome Measures
Name Time Method Terminal elimination rate constant Up to 120 hours after dose To evaluate rate of drug elimination
Apparent volume of distribution (Vz/F) Up to 120 hours after dose To evaluate extent of drug distribution in the body
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 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) Up to 120 hours after dose To evaluate drug exposure over specified measurement time frame
Apparent total clearance from plasma (CL/F) Up to 120 hours after dose To evaluate rate of drug clearance
Maximum plasma concentration (Cmax) Up to 120 hours after dose To evaluate peak drug concentration achieved during specified measurement time frame
Time to maximum plasma concentration (Tmax) Up to 120 hours after dose To evaluate time to achieve peak concentration during specified measurement time frame
Terminal elimination half-life (T1/2) Up to 120 hours after dose To evaluate time over which drug concentration is decreased by half
- Secondary Outcome Measures
Name Time Method Relative bioavailability (Frel) Over 120 hours after dose To compare single dose oral bioavailability in fed and fasted states
Trial Locations
- Locations (2)
CMAX Clinical Research
🇦🇺Adelaide, South Australia, Australia
Scientia Clinical Research
🇦🇺Randwick, New South Wales, Australia