A phase 1, single-part, non-randomised, open-label, six-period sequential crossover study designed to evaluate the pharmacokinetic profile of VDPHL01 following single dose administration of novel VDPHL01 modified release formulations in comparison to a reference minoxidil immediate release formulation in healthy subjects
Androgenetic alopecia
This is a non-randomised, open-label study. Healthy volunteers will receive single oral doses of up to 10 mg of a new tablet formulation of the test medicine in up to 5 study periods, and a single 2.5 mg oral dose of an approved and marketed reference product in one study period. Volunteers will be dosed in the fasted state in Periods 1 to 5, and they will be dosed in the fasted or fed state in Period 6 depending on the data from the previous study periods. There will be a minimum 7-day break between each dosing occasion. Volunteers will be discharged on Day 3 in each study period.
1. Must provide written informed consent 2. Must be willing and able to communicate and participate in the whole study 3. Aged 18 to 55 years inclusive at the time of signing informed consent 4. Must agree to adhere to the contraception requirements defined in the Clinical Protocol 5. Males or non-pregnant, non-lactating females 6. Participants who are healthy as determined by medical evaluation including medical history, physical examination, vital signs, single 12-lead ECG, clinical laboratory profiles (haematology, clinical chemistry and urinalysis), as deemed by the investigator or designee at screening 7. Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening 8. Weight ≥50 kg at screening 9. Willing to consume a high-fat breakfast, including pork
1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients 2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active 3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator 4. Subjects with a history of cholecystectomy or gallstones 5. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening 6. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are allowed 7. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results 8. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <80 mL/min using the Cockcroft-Gault equation 9. Evidence of orthostatic hypotension, defined as a drop in systolic blood pressure >20 mmHg upon standing, a drop in diastolic blood pressure >10 mmHg on standing or an increase in heart rate >30 bpm on standing. Or symptomatic dizziness, pre-syncope or syncope during the assessment of orthostatic hypotension 10. Any clinically significant abnormal finding on ECG at screening or pre-first dose 11. Resting supine heart rate >90 bpm 12. Resting supine systolic BP <90 mmHg 13. Resting supine diastolic BP <50 mmHg 14. Females who are pregnant or lactating (all female subjects must have a negative highly sensitive urine pregnancy test)↲ 15. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1 of Period 1, or less than 5 elimination half-lives prior to Day 1 of Period 1, whichever is longer 16. Donation of blood or plasma within the previous 3 m