A Study of Idazoxan in Healthy Participants

Terran Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: TR-01-XRR (1); Drug: TR-01-XRR (3); Drug: TR-01-XR; Drug: TR-01-XRS; Drug: TR-01-XRR (2); Drug: TR-01-IR; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05727189

TR01-XR-101

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 4 patient groups

Part 1 Single Dose

Experimental group

Description:

Parallel group comparison, single dose level of 5 forms of the investigational study drug.

Treatment:

Drug: TR-01-XRR (2)

Drug: TR-01-XRS

Drug: TR-01-XR

Drug: TR-01-XRR (3)

Drug: TR-01-XRR (1)

Part 2: Single escalating doses

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: TR-01-IR

Drug: TR-01-XRS

Drug: TR-01-XR

Drug: TR-01-XRR (1)

Part 3: Multiple Dose

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: TR-01-IR

Drug: TR-01-XRS

Drug: TR-01-XR

Drug: TR-01-XRR (1)

Part 4: Food Effects

Experimental group

Description:

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.

Treatment:

Drug: TR-01-XRR (1)