A Phase 1, Randomized, Open-Label Study of the Relative Bioavailability and Effect of Food on the Pharmacokinetics of a Novel Formulation of PRN2246 Compared to a Reference Formulation in Healthy Adult Participants
Clinical Network Services (CNS) Pty Ltd
14 participants
Oct 14, 2018
Interventional
Conditions
Summary
A Phase 1, randomized, 0pen-label study of the relative bioavailability and effect of food on the pharmacokinetics of a novel formulation of PRN2246 compared to a reference formulation. The study will be performed at a single-centre in healthy adult participants. This is a complete-crossover study where each participant will receive all three treatments.
Eligibility
Inclusion Criteria5
- Healthy adult male and/or female participants, 18 to 55 years of age (inclusive) at the time of screening
- Body mass index more than or equal to 18.0 and less than or equal to 30.5 (kg per m2) (inclusive) and a minimum body weight of 45 kg at screening
- Male participants with female partners of childbearing potential must be willing to practice true abstinence or use two highly effective methods of contraception (including one barrier method) from Day 1 until 3 months after their final dose of study drug
- Female participants must be surgically sterile or postmenopausal (no spontaneous menstrual period for at least 1 year), confirmed by follicle-stimulating hormone (FSH) more than 40 mIU per mL. Sterilization procedure must have been completed at least 6 months prior to the first study drug administration.
- Negative urine drug/alcohol breath testing at screening and check-in (Day -1). Screening urine drug and/or alcohol breath testing may be repeated once if deemed appropriate by the site investigator.
Exclusion Criteria10
- Pregnant or lactating women and male partners of women who are pregnant or lactating
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies
- Use of more than two tobacco/nicotine-containing or cannabis products per month within 6 months prior to the first study drug administration
- History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration
- Use of any over-the-counter medication, including herbal products, within the 7 days prior to Day 1, other than limited paracetamol use (less than or equal to 2 g/day). Use of any prescription medication within the 14 days prior to the first study drug administration or 5 half-lives, whichever is longer
- Blood donation or significant blood loss within 60 days prior to screening
- Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 60 days prior to the first study drug administration or 5 half-lives, whichever is longer
- Surgery within the past 3 months prior to the first study drug administration determined by the Investigator to be clinically relevant
- History of active treatment for tuberculosis within the past 5 years
- Regular alcohol consumption more than 14 units per week (1 unit equals 1 pint beer, 25 mL of 40 percent spirit, or a 125-mL glass of wine)
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Interventions
PRN2246-002 is a single-center, three-period, open-label, randomized, complete-crossover study in healthy adult participants. All participants will complete all three periods of the study. Beginning Day 1, participants will be randomized to the order of treatment (1, 2, and 3), with blood sampling for plasma PK over 24 hours after each dose of study drug. PRN2246 doses will be administered 48 hours apart. Treatments are as listed below: Treatment 1: Following an overnight fast, participants will receive a single 60mg oral dose of the liquid PRN2246 formulation (reference). Treatment 2: Following an overnight fast, participants will receive a single 60mg oral dose of tablet PRN2246 formulation (test). Treatment 3: Participants will receive a single 60mg oral dose of the tablet (4x15mg) formulation of PRN2246 (test) within 30 minutes of a standardized high-fat breakfast. Following discharge from the study unit in the morning of Day 6, participants will return for a follow-up (FU) assessment on Day 10 (plus or minus 1 day).
Locations(1)
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ACTRN12618001523291