Phase I trial (QSC300720)
Research type
Research Study
Full title
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
IRAS ID
1007785
Contact name
Timothy Durso
Contact email
Sponsor organisation
Veradermics Inc.
ISRCTN Number
ISRCTN57359805
Research summary
The Sponsor is developing the test medicine, VDPHL01, for the potential treatment of Androgenetic Alopecia (AGA), also known as male or female pattern hair loss. AGA is the most common type of hair loss, affecting up to 50% of males and females. This type of hair loss is related to both a genetically predetermined excessive response of the hair follicles to hormones called androgens, as well as higher levels of these hormones which lead to a shorter life cycle of hair growth and the growth of shorter and thinner strands of hair.\nThis one-part, six-period healthy volunteer study will compare how the body responds to different formulations of the test medicine (recipes) and compare the different formulations to an already approved and marketed reference product, minoxidil. It will also look at the safety and tolerability of the test medicine.\n\nThis study will take place at one non-NHS site, enrolling up to 16 male and female volunteers aged between 18 and 55.\n\nIn five Periods, volunteers will receive single oral doses of the test medicine as different recipes. In an additional Period, volunteers will receive a single oral dose of the reference product. 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.\n\nAll volunteers will receive a follow-up phone call 3 to 7 days post final dose.\n\nVolunteers’ blood and urine will be taken throughout the study for analysis of the test medicine and for the volunteers’ safety.\n\nVolunteers are expected to be involved in this study for approximately 14 weeks from screening to the follow-up call.\n\nAs this is a Phase I study in healthy volunteers, no lay summary of results has been provided, for reasons of commercial confidentiality.\n\n\n
REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0521
Date of REC Opinion
19 Sep 2023
REC opinion
Further Information Favourable Opinion