Healthy
Conditions
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.
Interventions
DRUGTR-01-XRR (1)
Extended-release form
DRUGTR-01-XRR (2)
Extended-release form
DRUGTR-01-XRR (3)
Extended-release form
DRUGTR-01-XRS
Extended-release form
DRUGTR-01-XR
Extended-release form
DRUGTR-01-IR
Active comparator
DRUGPlacebo
Placebo comparator
Sponsors
Terran Biosciences Australia Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Part 1: Open Label Part 2: Double-blind Placebo Controlled Part 3: Double-blind Placebo Controlled Part 4: Open Label
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Relative bioavailability (Frel) | Over 120 hours after dose | To compare single dose oral bioavailability in fed and fasted states |
Countries
Australia
Contacts
STUDY_DIRECTORRobert Fishman, MD
Clinical Lead Consultant
Outcome results
None listed