Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03450720
• Date of registration: 23/02/2018
• Prospective Registration: No
• Primary sponsor: Galapagos NV
• Public title: Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis
• Scientific title: Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG2737 Administered as Oral Suspension in Male Subjects With Cystic Fibrosis
• Date of first enrolment: June 28, 2017
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03450720
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Olivier Van de Steen, MD MBA
• Affiliation: Galapagos NV

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male subject =18 years of age on the day of signing the informed consent form (ICF).

- A confirmed clinical diagnosis of CF.

- Two mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
belonging to class I and/or class II and/or class III (documented in the subject's
medical record or CF registry).

- Weight =40 kg.

- Exocrine pancreatic insufficiency (documented in the subject's medical record).

- Stable concomitant medication regimen for at least 2 weeks prior to study drug
administration.

- Forced expiratory volume in one second (FEV1) =40% of predicted normal for age, gender
and height at screening (pre- or postbronchodilator).

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.

- Unstable pulmonary status or respiratory tract infection (including rhinosinusitis)
requiring a change in therapy within 2 weeks prior to study drug administration.

- History of hepatic cirrhosis with portal hypertension (e.g.,signs/symptoms of
splenomegaly, esophageal varices).

- Use of CFTR modulator therapy (e.g., lumacaftor or ivacaftor) within 2 weeks prior to
study drug administration.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: GLPG2737 single dose

Primary Outcome(s)

Area under the plasma concentration-time curve from time zero until 48 hours post-dose (AUC0-48h) [Time Frame: Between day 1 pre-dose and 48 hours post-dose.]

Terminal plasma elimination rate constant (ke) [Time Frame: Between day 1 pre-dose and 48 hours post-dose.]

Apparent terminal elimination half-life ( t1/2) [Time Frame: Between day 1 pre-dose and 48 hours post-dose.]

Time of occurrence of Cmax for GLPG2737(tmax) [Time Frame: Between day 1 pre-dose and 48 hours post-dose.]

Area under the plasma concentration-time curve for GLPG2737 (AUC0-24h) [Time Frame: Between day 1 pre-dose and 48 hours post-dose.]

Maximum observed plasma concentration (Cmax) of GLPG2737and its metabolite. [Time Frame: Between day 1 pre-dose and 48 hours post-dose.]

Plasma concentration observed at 24 hours post-dos (C24h) [Time Frame: Between day 1 pre-dose and 48 hours post-dose.]

Secondary Outcome(s)

Number of subjects with adverse events. [Time Frame: Between screening and 15 days post-dose]

Secondary ID(s)

GLPG2737-CL-104

2017-000449-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors