A Phase 1, Single-Center, Open-label Study to Evaluate the Pharmacokinetics of PRN1008 in Healthy Male and Female Volunteers

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000614594
• Date of registration: 12/06/2015
• Prospective Registration: Yes
• Primary sponsor: Clinical Network Services (CNS) Pty Ltd
• Public title: A Phase 1, Single-Center, Open-label Study to Evaluate the Pharmacokinetics of PRN1008 in Healthy Male and Female Volunteers
• Scientific title: A Phase 1, Single-Center, Open-label Study to Evaluate the Pharmacokinetics of PRN1008 in Healthy Male and Female Volunteers
• Date of first enrolment: 22/06/2015
• Target sample size: 12
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000614594.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Bio-availability;
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: Dr Janakan Krishnarajah

• Name: Mr Simon Scott

Key inclusion & exclusion criteria

Inclusion criteria: *Healthy adult male or non-pregnant non-lactating females, 40 to 75 years of age (inclusive) at the time of screening.
*Body mass index (BMI) equal to or greater than 18 and equal to or less than 35 (kg/m2) (inclusive) and a minimum body weight of 45 kg.
*Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
*Negative urine drug/alcohol testing at screening and check-in (Day -1).
Exclusion criteria: *Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
*History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration.
*History of any significant (as determined by the Investigator) drug-related allergic reactions such as, anaphylaxis, Stevens-Johnson syndrome, urticaria or multiple drug allergies.
*Blood donation or significant blood loss within 30 days prior to screening.
*Plasma donation within 14 days prior to the first study drug administration.
*Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 30 days prior to the first study drug administration or 5 half-lives, whichever is longer.
*Surgery within the past three months prior to the first study drug administration determined by the PI to be clinically relevant.
*Personal or family history of prolonged QT syndrome or family history of sudden death.
*QTcF greater than 450 msec (males) or greater than 470 msec (females) or less than 300 msec at screening or baseline visit, unless deemed clinically insignificant by the Investigator.
*Seated resting systolic blood pressure (SBP) greater than 150 or less than 90 mm Hg, or diastolic blood pressure greater than 95 or less than 50 mm Hg.
*History or presence of any other medical condition that makes the participant unsuitable for the study in the opinion of the Investigator.


Age minimum: 40 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Inflammatory and Immune System - Autoimmune diseases

Rheumatoid Arthritis;Inflammatory Bowel Disease;Systemic Lupus Erythematosus;
Rheumatoid Arthritis
Inflammatory Bowel Disease
Systemic Lupus Erythematosus

Intervention(s)

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.

Primary Outcome(s)

To evaluate the relative bioavailability of a single oral dose of PRN1008 when administered as a liquid formulation and a capsule formulation in the fasted state.

This will be assessed via administering PRN1008 as a capsule compared with the PRN1008 as liquid formulation and then taking pharmacokinetic blood samples from subjects at the specified times note din primary time points for analyses.[Pre-dose (time 0 minutes ) and at 30min, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 10hr, 12hr and 24 hrs after PRN1008 dosing (both capsule and oral formulation)]

Secondary Outcome(s)

To evaluated the safety and tolerability of PRN1008 (capsule and liquid formulations) tolerability, including the assessment of physical examinations, ECGs, vital signs, clinical laboratory results and adverse events. This a composite secondary outcome.[*Physical examination: at screening, Day -1, Day 1, Day 2, Day 3, Day 4 and follow up visits.
*ECG: at screening and Day -1. Then at various time points on Day 1 and Day 3.
*Vitals: at screening and Day-1 then various time points on Day 1, Day 2, Day 3, Day 4 and the follow up visit.
*Clinical Laboratory Tests: at screening and Day-1, then Day 4 and follow up visit.
*Adverse Events: all visits from screening through to the follow up visit.]

Secondary ID(s)

NIL

Source(s) of Monetary Support

Principia Biopharma Australia Pty Ltd

Ethics review

Status: Approved
Approval date:
Contact:

Bellberry Limited