Drug-drug interaction study with GLPG3667 and midazolam (QSC205019)
Research type
Research Study
Full title
An open-label, fixed-sequence, drug-drug interaction study in healthy subjects to evaluate the effect of GLPG3667 on the pharmacokinetics of midazolam, a sensitive index substrate of CYP3A4
IRAS ID
291488
Contact name
Ekaterina Tankisheva
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2020-004846-12
Duration of Study in the UK
0 years, 1 months, 11 days
Research summary
Summary of Research
The sponsor is developing a new test medicine, GLPG3667, to treat auto inflammatory and autoimmune conditions such as rheumatoid arthritis, psoriasis, psoriatic arthritis, multiple sclerosis and inflammatory bowel disease.
The test medicine (GLPG3667) is thought to work by inhibiting a pathway within the body which promotes improper activation of the immune system and therefore, inflammation in these conditions.
The test medicine is noted to reduce the activity of an enzyme (protein) which is involved in breakdown of certain other medicines. One of these is midazolam, which is a marketed medicine used to treat agitation during anaesthesia. Midazolam is available as an injectable formulation but will be given to volunteers by mouth. In this study, the impact of the test medicine (GLPG3667) on how midazolam is broken down by the body will be looked at.
This is not the first time this test medicine has been given to people. We will also look at the safety and tolerability of the test medicine.The study will consist of 1 study period involving up to 14 healthy male and female volunteers. 14 volunteers are being enrolled to get 12 evaluable subjects. The volunteers will attend the research site for 1 study visit of 9 overnight stays where they will be dosed with midazolam on Day 1 and Day 7. They will be dosed with 150 mg of the test medicine (GLPG3667) on Day 3 through to Day 8. The test medicine (150mg GLPG3667) will be dosed as 2 x 75 mg oral capsules, accompanied with 240 ml of water.
The day of discharge is on Day 9 which is 8 days after the first dose with the test medicine. Volunteers must attend a follow up visit which takes place 11 to 17 days after the last dose to ensure their safety and wellbeing.
Summary of Results
Given that this is a Phase I trial, no lay summary of results has been provided for reasons of commercial confidentiality.
REC name
Wales REC 2
REC reference
20/WA/0335
Date of REC Opinion
10 Dec 2020
REC opinion
Favourable Opinion