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
- Conditions
- Immune-mediated neurologic disordersNeurological - Multiple sclerosis
- Registration Number
- ACTRN12618001523291
- Lead Sponsor
- Clinical Network Services (CNS) Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 14
1.Healthy adult male and/or female participants, 18 to 55 years of age (inclusive) at the time of screening
2.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
3.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
4.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.
5.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.
1.Pregnant or lactating women and male partners of women who are pregnant or lactating
2.Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies
3.Use of more than two tobacco/nicotine-containing or cannabis products per month within 6 months prior to the first study drug administration
4.History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration
5.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
6.Blood donation or significant blood loss within 60 days prior to screening
7.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
8.Surgery within the past 3 months prior to the first study drug administration determined by the Investigator to be clinically relevant
9.History of active treatment for tuberculosis within the past 5 years
10.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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relative oral bioavailability (area under the curve from time 0 to the last quantifiable concentration (AUClast), area under the curve from time 0 to infinity (AUC0-inf), and the maximum observed concentration (Cmax) of PRN2246 when administered as a reference liquid formulation compared to the test tablet formulation under fasting conditions.[Blood samples for PRN2246 PK will be collected predose (prior to dosing) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours after PRN2246 dosing on Days 1, 3, and 5.];Impact of food on PRN2246 AUClast, AUC0-inf, and Cmax when administered as a tablet (test formulation) under fasting and fed conditions<br>[Blood samples for PRN2246 PK will be collected predose (prior to dosing) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours after PRN2246 dosing on Days 1, 3, and 5.]
- Secondary Outcome Measures
Name Time Method