GLPG2737-CL-105 Assessment of multiple oral doses of GLPG2451/GLPG2222
Research type
Research Study
Full title
Assessment of safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of the combination of GLPG2451 and GLPG2222, with or without GLPG2737, in adult subjects with cystic fibrosis
IRAS ID
237093
Contact name
Alexander Horsley
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2017-001067-20
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
This is a Phase 1b, multi-center, open-label, non-randomised multiple cohorts study. The purpose of this study is to assess the safety, tolerability, PK, and pharmacodynamics of multiple doses of a combination treatment of GLPG2451 and GLPG2222, with and without GLPG2737, in adult participants with Cystic Fibrosis (CF).
Approximately 24 participants are planned to take part in this study for approximately 32 weeks (including a 28-day screening period).There will be three cohorts with adult participants with Cystic Fibrosis (CF) enrolled. Cohort A, B and C will have 8 participants in each cohort.
- Cohort A; will enrol adult CF participants homozygous for the F508del mutation.
- Cohort B; will enrol adult CF participants heterozygous for the F508del CFTR mutation with a potentiator non-responsive mutation on the second allele.
- Cohort C; will include adult CF participants homozygous for F508del mutation (part 2), enrolled following the review of the safety and PK results from the first cohort after 28 days of follow-up.Dual combination (GLPG2451 and GLPG2222) will be administered for 14 days, followed by the triple combination (GLPG2451, GLPG2222 and GLPG2737) for 14 days, without washout in between the sequential treatment periods.
Nasal brushings will be collected for all participants in Cohort A while participants in Cohorts B and C will be able to choose to participate in the optional sub-study, where nasal brushings will be collected.
Eye examinations will be performed at the screening period to exclude potential participants with cataract and two additional ophthalmological assessments, one at the end of the dosing period and the other at the end of the 6 months follow-up period.
Belgium, Bulgaria, Germany, Greece, Netherlands, Republic of Serbia, Sweden, United Kingdom will take part in this study.
Enrolment timelines;
Planned start date UK: 15 February 2018
Last Patient In: 15 May 2019.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
18/NW/0006
Date of REC Opinion
26 Mar 2018
REC opinion
Further Information Favourable Opinion