ACT774312 SADMAD Study in Healthy Volunteers/ poor CYP2C9 metabolizers
Research type
Research Study
Full title
A three-part single-center, Phase 1 study to assess the tolerability, safety, pharmacokinetics (including food interaction), and pharmacodynamics of ascending single and multiple doses of ACT-774312 in healthy subjects and to investigate the pharmacokinetics of a single dose of ACT-774312 in healthy CYP2C9 poor metabolizers.
IRAS ID
209741
Contact name
Jim Bush
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd
Eudract number
2016-002298-37
Duration of Study in the UK
0 years, 7 months, 17 days
Research summary
AC-084 is an Investigational Medicinal Product (IMP) being developed for the treatment of allergic disorders such as asthma, allergic rhinitis (runny nose), atopic dermatitis (allergic skin inflammation), and eosinophilic esophagitis (heartburn). AC-084 acts by blocking some receptor molecules on the surface of blood cells which result in a reduction in the inflammatory molecule released.\n\nThe purposes of this first in man study are to assess the safety and tolerability when it is given as single and multiple oral dose to healthy volunteers and poor metabolisers (individuals who cannot breakdown the drug because of genetic variation), to understand how body breaks down the drug, effect of food on drug absorption, the effect on the heart and also to learn what effect the drug has on blood cells.\n\n\nThis study will be conducted in three parts, Part A will be done as a single dose study, starting with a low dose and subsequent groups getting a higher dose. There will be 7 groups in this part. The first two subjects in each group will be dosed 24 hours before the rest of the group gets the medication. Each group will have 8 volunteers, two of them will receive Placebo (dummy drug). In group A5 a single dose will be administered in a fasted state in period 1 and in a fed state in period 2.\n In part B, subjects will receive multiple oral doses of ACT-774312 or placebo once daily in the morning in the fasted condition. The duration of administration will be at least 4 days and each dose level will be investigated in a new cohort of 8 healthy male and female subjects (3 male subjects on active drug, 1 on placebo, and 3 female subjects on active drug, 1 on placebo). The first two subjects in each group will be dosed 24 hours before the rest of the group gets the medication. Patients will not be dosed until a steady state has been reached in the first two subjects\nIn part C one dose level of ACT-774312 will be assessed, currently foreseen to be 100 mg, available as a capsule. The study treatment will be administered in the morning of Day 1 in fasted conditions to a single group of subjects who are poor metabolisers for CYP2C9 (I.e. people who have very low activity of the 2C9 enzyme .\n
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0261
Date of REC Opinion
12 Aug 2016
REC opinion
Further Information Favourable Opinion