A Study of the Safety, Tolerability and Pharmacokinetics of Idazoxan in Healthy Participants

Sponsor

Terran Biosciences Australia Pty Ltd (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05727189

Collaborator

(none)

110

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

18.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: TR-01-XRR (1) Drug: TR-01-XRR (2) Drug: TR-01-XRR (3) Drug: TR-01-XRS Drug: TR-01-XR Drug: TR-01-IR Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Part 1: Parallel group comparison, single dose level of 5 forms of the investigational study drug. Part 2: Parallel group comparison, single dose escalation (3 dose levels) of 4 forms investigational study drug and placebo. Part 3: Placebo controlled, multiple dose cross-over within 4 parallel group comparison. Part 4: Single-dose food effect cross-over.Part 1: Parallel group comparison, single dose level of 5 forms of the investigational study drug. Part 2: Parallel group comparison, single dose escalation (3 dose levels) of 4 forms investigational study drug and placebo. Part 3: Placebo controlled, multiple dose cross-over within 4 parallel group comparison. Part 4: Single-dose food effect cross-over.

Masking:

Double (Participant, Investigator)

Masking Description:

Part 1: Open Label Part 2: Double-blind Placebo Controlled Part 3: Double-blind Placebo Controlled Part 4: Open Label

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1 Single Dose Parallel group comparison, single dose level of 5 forms of the investigational study drug.	Drug: TR-01-XRR (1) Extended-release form Drug: TR-01-XRR (2) Extended-release form Drug: TR-01-XRR (3) Extended-release form Drug: TR-01-XRS Extended-release form Drug: TR-01-XR Extended-release form
Experimental: Part 2: Single escalating doses Parallel group comparison, single p.o. dose escalation (3 dose levels) of 4 forms investigational study drug and placebo. Dose levels separated by 7-day washout periods. Doses to be determined by review of data from Part 1.	Drug: TR-01-XRR (1) Extended-release form Drug: TR-01-XRS Extended-release form Drug: TR-01-XR Extended-release form Drug: TR-01-IR Active comparator Drug: Placebo Placebo comparator
Experimental: Part 3: Multiple Dose 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.	Drug: TR-01-XRR (1) Extended-release form Drug: TR-01-XRS Extended-release form Drug: TR-01-XR Extended-release form Drug: TR-01-IR Active comparator Drug: Placebo Placebo comparator
Experimental: Part 4: Food Effects 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.	Drug: TR-01-XRR (1) Extended-release form

Outcome Measures

Primary Outcome Measures

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
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 rate constant [Up to 120 hours after dose]
To evaluate rate of drug elimination
Terminal elimination half-life (T1/2) [Up to 120 hours after dose]
To evaluate time over which drug concentration is decreased by half
Apparent total clearance from plasma (CL/F) [Up to 120 hours after dose]
To evaluate rate of drug clearance
Apparent volume of distribution (Vz/F) [Up to 120 hours after dose]
To evaluate extent of drug distribution in the body

Secondary Outcome Measures

Relative bioavailability (Frel) [Over 120 hours after dose]
To compare single dose oral bioavailability in fed and fasted states

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CMAX Clinical Research	Adelaide	South Australia	Australia	5000

Sponsors and Collaborators

Terran Biosciences Australia Pty Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Terran Biosciences Australia Pty Ltd

ClinicalTrials.gov Identifier:

NCT05727189

Other Study ID Numbers:

TR01-XR-101

First Posted:

Feb 14, 2023

Last Update Posted:

Feb 14, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 14, 2023