A Study of Idazoxan in Healthy Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05727189
• Other study ID #: TR01-XR-101
• Status: Recruiting
• Phase: Phase 1
• Start date: February 14, 2023
• Est. completion date: March 2024

Study information

• Verified date: November 2023
• Source: Terran Biosciences Australia Pty Ltd
• Contact: Terran Clinical
• Phone: +1 (646) 837-5687
• Email: info[@]terranbiosciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• TR-01-XRR (1)
Extended-release form
• TR-01-XRR (2)
Extended-release form
• TR-01-XRR (3)
Extended-release form
• TR-01-XRS
Extended-release form
• TR-01-XR
Extended-release form
• TR-01-IR
Active comparator
• Placebo
Placebo comparator

Locations

Country	Name	City	State
Australia	CMAX Clinical Research	Adelaide	South Australia
Australia	Scientia Clinical Research	Randwick	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Terran Biosciences Australia Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion up to 25 days after initial dose
Primary	Area under the plasma concentration-time curve (AUC)	To evaluate drug exposure over specified measurement time frame	Up to 120 hours after dose
Primary	Maximum plasma concentration (Cmax)	To evaluate peak drug concentration achieved during specified measurement time frame	Up to 120 hours after dose
Primary	Time to maximum plasma concentration (Tmax)	To evaluate time to achieve peak concentration during specified measurement time frame	Up to 120 hours after dose
Primary	Terminal elimination rate constant	To evaluate rate of drug elimination	Up to 120 hours after dose
Primary	Terminal elimination half-life (T1/2)	To evaluate time over which drug concentration is decreased by half	Up to 120 hours after dose
Primary	Apparent total clearance from plasma (CL/F)	To evaluate rate of drug clearance	Up to 120 hours after dose
Primary	Apparent volume of distribution (Vz/F)	To evaluate extent of drug distribution in the body	Up to 120 hours after dose
Secondary	Relative bioavailability (Frel)	To compare single dose oral bioavailability in fed and fasted states	Over 120 hours after dose