A study to investigate FDL169 in healthy female volunteers
Research type
Research Study
Full title
A Phase I dose escalation study to assess the pharmacokinetics (PK) of FDL169 in healthy female volunteers
IRAS ID
191273
Contact name
Khalid Abou-Farha
Contact email
Sponsor organisation
Flatley Discovery Lab
Eudract number
2015-003090-15
Duration of Study in the UK
0 years, 2 months, 13 days
Research summary
This open-label, two Part Phase I study is looking at a drug known as FDL169, which is a drug designed for the treatment of Cystic Fibrosis (CF). The main purpose of the study is to look at the pharmacokinetics of single ascending doses and multiple doses at one dose level of FDL169 in healthy female volunteers. The safety and tolerability of single and multiple oral doses of FDL169 in healthy adult female subjects will also be examined.
The population eligible to take part in the study includes healthy female subjects aged 18 to 55 years, with a body mass index of >19 and <30 kg/m2. They must be in good health, as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests completed during screening at Simbec.
The study will be conducted in two parts. Part 1 is a single ascending dose (SAD) design, which will last approximately 9 weeks for each individual (namely, from the screening visit to the post-study visit); each dosing period will follow a dose-escalation schedule. Part 2 is a multiple dose design, of approximately 4 weeks for each individual. The dose and dosing interval for Part 2 will be based on a review of all available safety and PK data from the first 2 or 3 dosing periods in Part 1, but will not exceed 800mg.
16 healthy, female participants are planned to be enrolled in this study, with 8 subjects enrolled in each Part.
The study will be conducted at Simbec, which is a commercial organisation.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0651
Date of REC Opinion
18 Nov 2015
REC opinion
Favourable Opinion