DDI PK Effect Study of Itraconazole and Voriconazole on GLPG1690
Research type
Research Study
Full title
A Phase I, Open-Label, Randomized, Drug-Drug Interaction Study to Evaluate the Effect of itraconazole and voriconazole on the Single-Dose Pharmacokinetics of GLPG1690 in Healthy Male Subjects
IRAS ID
241767
Contact name
Ekaterina Tankisheva
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2017-004357-16
Duration of Study in the UK
0 years, 2 months, 18 days
Research summary
The Sponsor is developing the test medicine, GLPG1690, for the potential treatment of lung diseases, such as idiopathic pulmonary fibrosis (IPF). IPF is a condition in which the lungs become scarred and breathing becomes increasingly difficult. It is currently unclear what causes it, but it usually affects people around 70-75 years of age and is rare in people under 50.
The purpose of the study is to see how well GLPG1690 is taken up by the body when taken with Itraconazole or voriconazole. Itraconazole and voriconazole are marketed medicines that are used to treat a number of fungal infections. The study will also look at the safety and tolerability of GLPG1690 when taken alone and with either itraconazole or voriconazole.
The study will consist of 3 periods involving at least 18 healthy male volunteers randomized into one of 6 treatment sequences. All volunteers will take part in all 3 periods in the treatment sequence they have been randomized to.
REC name
Wales REC 2
REC reference
18/WA/0062
Date of REC Opinion
12 Mar 2018
REC opinion
Further Information Favourable Opinion