None listed
Conditions
Brief summary
Placebo-controlled, First-In-Human study assessing the safety and tolerability of PRN473 in healthy volunteers. Partipants in Part A of the study will recive a single dose of PRN473. Partipants in Part B of the study will recieve one dose of PRN473 per day for up to 14 days.
Interventions
Placebo-controlled, First-In-Human study assessing the safety and tolerability of PRN473.
Approximately 64 participants in up to 6 cohorts will take part in Part A of the study. Participants in Part A of the study will receive a single dose of PRN473 (starting dose 50mg and increasing each cohort thereafter). Part A participants will receive a liquid formulation whilst fasting with the exception of 2 cross over cohorts; participants in Cohort 4a will receive the liquid formulation administered
Placebo-controlled, First-In-Human study assessing the safety and tolerability of PRN473. Approximately 64 participants in up to 6 cohorts will take part in Part A of the study. Participants in Part A of the study will receive a single dose of PRN473 (starting dose 50mg and increasing each cohort thereafter). Part A participants will receive a liquid formulation whilst fasting with the exception of 2 cross over cohorts; participants in Cohort 4a will receive the liquid formulation administered with and without food (with up to a 7 day washout between doses) and participants in Cohort 4b will be administered a tablet equivalent with and without food (with up to a 7 day washout between doses). Approximately 50 participants in up to 5 cohorts will take part in Part B of the study. Participants in Part B of the study will receive one dose of PRN473 (tablet or liquid formulation) per day for up to 14 days (doses to be assigned based on data from part A i.e. a dose that gives roughly 30% occupancy of the target). Tablet or liquid formulation will be chosen on the basis of emerging PK and PD data from Part A of the study. Study subjects are domiciled during the study and adherence will be monitored by study staff observations and notes, and tablet accountability or weighing the dosing syringes before and after dosing as applicable.
Sponsors
Clinical Network Services
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1.adult males and/or females, 18 to 55 years of age (inclusive) at the time of screening 2. Body mass index (BMI) >18.0 and < 30.5 (kg/m2) (inclusive) 3. Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent 4. If male, agrees to be sexually abstinent or to use a condom or other adequate method of contraception 5. Female participants must be surgically sterile or post-menopausal 6. Negative urine drug/alcohol breath testing at screening and check-in (Day -1).
Exclusion criteria
1. Pregnant or lactating females, and male partners of women who are pregnant or lactating 2. Females of child-bearing potential 3. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV) 4. Any active acute or chronic disease judged to be clinically significant by the Investigator 5. Use of more than 1-2 tobacco/nicotine-containing products per month within 6 months prior to begining the study 6. History or presence of alcoholism or drug abuse within the 2 years prior to begining the study 7. History of any significant (as determined by the Invest igator) drug-related allergic reactions 8. Use of any over-the-counter (OTC) medication 9. Participation in another clinical trial of a drug or device within 60 days. 10. Surgery within the past three months 11. Hypertension 12. Hypersensitivity to lactose 13. Regular alcohol consumption >14 units per week (1 unit = 1/2 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine) 14. History or presence of any clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease 15. Any acute illness within 30 days prior to Day 1 of the study
Outcome results
None listed