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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Single Dose | Experimental | Parallel group comparison, single dose level of 5 forms of the investigational study drug. |
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| Part 2: Single escalating doses | Experimental | 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. |
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| Part 3: Multiple Dose | Experimental | 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. |
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| Part 4: Food Effects | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TR-01-XRR (1) | Drug | Extended-release form |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Area under the plasma concentration-time curve (AUC) | To evaluate drug exposure over specified measurement time frame | Up to 120 hours after dose |
| Maximum plasma concentration (Cmax) | To evaluate peak drug concentration achieved during specified measurement time frame | Up to 120 hours after dose |
| Time to maximum plasma concentration (Tmax) | To evaluate time to achieve peak concentration during specified measurement time frame | Up to 120 hours after dose |
| Terminal elimination rate constant | To evaluate rate of drug elimination | Up to 120 hours after dose |
| Terminal elimination half-life (T1/2) | To evaluate time over which drug concentration is decreased by half | Up to 120 hours after dose |
| Apparent total clearance from plasma (CL/F) | To evaluate rate of drug clearance |
| Measure | Description | Time Frame |
|---|---|---|
| Relative bioavailability (Frel) | To compare single dose oral bioavailability in fed and fasted states | Over 120 hours after dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Fishman, MD | Clinical Lead Consultant | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia Clinical Research | Randwick | New South Wales | 2031 | Australia | ||
| CMAX Clinical Research |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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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.
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Part 1: Open Label Part 2: Double-blind Placebo Controlled Part 3: Double-blind Placebo Controlled Part 4: Open Label
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| TR-01-XRR (2) | Drug | Extended-release form |
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| TR-01-XRR (3) | Drug | Extended-release form |
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| TR-01-XRS | Drug | Extended-release form |
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| TR-01-XR | Drug | Extended-release form |
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| TR-01-IR | Drug | Active comparator |
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| Placebo | Drug | Placebo comparator |
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| Up to 120 hours after dose |
| Apparent volume of distribution (Vz/F) | To evaluate extent of drug distribution in the body | Up to 120 hours after dose |
| Adelaide |
| South Australia |
| 5000 |
| Australia |