Trial Details

Not Recruiting
Basic Information
Clinical ID c2990
Identifier ACTRN12615000936527
Trial Title Relative Bioavailability and Effect of Food and Esomeprazole on the Pharmacokinetics of PRN1008 in Healthy 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, four-period, open-label, complete crossover (meaning subjects will receive all treatments) study to investigate: * The single dose pharmacokinetics of PRN1008 when administered as a liquid formulation compared to a tablet formulation under fasted conditions (no food for at least 8 hours prior to dosing, water permissible until 1 hour pre-dose). * The effect of a meal on the single dose pharmacokinetics of PRN1008 when administered as a tablet formulation. * The effect of prior administration of a Proton Pump Inhibitor on the single dose pharmacokinetics of PRN1008 when administered as a tablet formulation. Participants will be screened for participation 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, 3, 5 and 10, and will remain in the clinic up to Day 11, after collection of the final PK sample. All participants will complete all four Periods of the study Participants will be randomized to order of treatment (1, 2 & 3) for the first three Periods. All participants will receive Treatment 4 as the final treatment. Therefore, the final Period will be identical for all participants. Treatments are as listed below. Doses will be administered approximately 48 hours apart for the first three treatments: 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. Participants will be in a fasted state (i.e an overnight fast -no food-of at least 8 hours, water permissible until 1 hr pre-dose).Food will be restricted until 4 hours after dosing. Treatment
Participant Information
Sponsor Clinical Network Services 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 -