Trial Details

Not Recruiting
Basic Information
Clinical ID c3005
Identifier ACTRN12615000614594
Trial Title A Phase 1, Single-Center, Open-label Study to Evaluate the Pharmacokinetics of PRN1008 in Healthy Male and Female Volunteers
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Rheumatoid Arthritis;Inflammatory Bowel Disease;Systemic Lupus Erythematosus; Rheumatoid Arthritis Inflammatory Bowel Disease Systemic Lupus Erythematosus;Inflammatory and Immune System - Autoimmune diseases
Interventions This will be a single-center, two-period, open-label study to investigate the single dose pharmacokinetics of PRN1008 when administered as a liquid formulation (at 300mg) compared to a capsule formulation under fasted conditions (also at a dosage of 300mg). Participants will be screened for participation in this study within 28 days before dosing. Participants will be admitted to the study unit the day before dosing (Day -1), then dosed in the mornings of Days 1 and 3, and will remain in the clinic up to Day 4, after collection of the final PK sample. Participants will be randomized to one of the two possible orders in which the following treatments will be completed. Doses will be approximately 48 hours apart: *Treatment 1: Immediately prior to and following a single oral 300 mg dose of PRN1008 liquid formulation, blood samples will be obtained over a period of 24 hours for determination of the PRN1008 PK profile. *Treatment 2: Immediately prior to and following a single oral 300 mg dose of PRN1008 capsule formulation, blood samples will be obtained over a period of 24 hours for determination of the PRN1008 PK profile. Following discharge from the study unit, subjects will return for a follow-up assessment 7 plus or minus 2 days after final study drug administration.
Participant Information
Sponsor Clinical Network Services (CNS) Pty Ltd
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, OLDER_ADULT
Study Design
Study Type Interventional
Phase PHASE1
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -