A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of the combination of GLPG3067, GLPG2222 and GLPG2737 in adult patients with cystic fibrosis

Phase 1

• Conditions: Cystic Fibrosis; MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Body processes [G] - Genetic Phenomena [G05]

• Registration Number: EUCTR2018-000098-61-GB
• Lead Sponsor: Galapagos NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-01
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 144

Inclusion Criteria

- Male or female subject =18 years of age
- A confirmed clinical diagnosis of CF as documented in the subject’s medical records.
- Eligible CFTR genotype (confirmed during screening period):
Part I: homozygous for the F508del CFTR mutation
Part II: heterozygous for the F508del CFTR mutation, i.e., a mutation on the second allele, which is non-responsive to potentiator.
- Body mass index (BMI) =18 kg/m² during screening.
- Stable concomitant medication for CF (including pulmonary CF, diabetes, pancreatic enzymes, as applicable) in the opinion of the investigator, for at least 4 weeks prior to the first IMP administration, and planned continuation of the same concomitant medication regimen for the duration of the study (including the follow-up visit).
- Forced expiratory volume in 1 second (FEV1) =40% and =90% of predicted normal for age, sex and height (pre- or post-bronchodilator) during screening.
- Sweat chloride concentration =60 mmol/L at screening.

Reference is made to the protocol for a complete overview of the
inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

- History of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator. This includes CF pulmonary disease with frequent exacerbations and short periods of stability (e.g., <3 months).
- Worsened pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 4 weeks prior to the first IMP administration.
- Need for supplemental oxygen during the day, and >2 liter per minute while sleeping.
- History of hepatic cirrhosis with portal hypertension (e.g., signs/symptoms of splenomegaly, esophageal varices).
- Use of any moderate or strong inhibitor(s) or inducer(s) of cytochrome P450 (CYP) type 3A4 (CYP3A4) within 4 weeks prior to the first IMP administration (e.g., clarithromycin, itraconazole, ketoconazole, telithromycin, rifampin, carbamazepine) (see Appendix 2).
- Use of CFTR modulator therapy (e.g., lumacaftor, tezacaftor and/or ivacaftor) within 4 weeks prior to the first IMP administration.
- Abnormal liver function test during screening, defined as AST and/or ALT and/or alkaline phosphatase (ALP) and/or gamma-glutamyl transferase (GGT) =3x the upper limit of normal (ULN), and/or total bilirubin >1.5 times ULN.

Reference is made to the protocol for a complete overview of the
exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified