Safety and PK of VX-440 with VX-661/Ivacaftor in Healthy Adults
Research type
Research Study
Full title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination with VX-661/Ivacaftor in Healthy Adult Subjects
IRAS ID
206890
Contact name
Gemma Pilkington
Contact email
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Eudract number
2016-000762-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 17 days
Research summary
The study drugs, called VX-440, VX-661 and Ivacaftor are being developed by Vertex Pharmaceuticals Incorporated for the treatment of cystic fibrosis (CF).\n\nCF is a genetic disease that is caused by a faulty gene which means that some cells struggle to move salt and water into or out of the cell. This leads to a build-up of thick, sticky mucus in the body’s tubes and passageways\n\nIvacaftor is a licensed drug (it can be prescribed by a GP) and is already being used for the treatment of CF. In the United Kingdom it is marketed under the trade name Kalydeco.\n\nVX-440 isn’t a licenced drug (an experimental medicine) and is currently being given as single and multiple doses in healthy volunteers as part of another clinical trial in the Netherlands. So far the doses given show that the drug is safe and well tolerated. Similar doses will be administered in this study.\n\nVX-661 is another experimental medicine that has previously been studied in healthy volunteers and CF patients by itself and in combination with ivacaftor.\n\nThis will be the first time that VX-440 has been given with VX-661 and ivacaftor together. The main purpose of this study is to see if VX-440 is safe and well tolerated when taken in combination with VX-661 and ivacaftor. We will look at how this combination of medications effect the body in healthy volunteers before they are tested in patients with Cystic Fibrosis.\n\nSome volunteers will receive placebos (‘dummy drugs’ containing no active ingredients) to prevent the study results from being influenced in any way and to compare against the study drugs.\n\nAll study drugs are in tablet form and will be taken following a meal containing a minimum specified fat content.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0430
Date of REC Opinion
23 Jun 2016
REC opinion
Favourable Opinion