Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.

Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG3067 Administered as Solid Formulation in Male Subjects With Cystic Fibrosis.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03589313

Enrollment

Registered

2018-07-17

Start date

2018-02-12

Completion date

2018-03-26

Last updated

2018-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Brief summary

This clinical study is a Phase I, open-label, single-center study designed to evaluate the pharmacokinetics profile of a single oral dose of GLPG3067 in adult male subjects with cystic fibrosis in fed state.

Interventions

DRUGGLPG3067 single dose

GLPG3067 film coated tablets provided at Day 1.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male subject ≥18 years of age on the day of signing the ICF. * A confirmed clinical diagnosis of CF. * Exocrine pancreatic insufficiency (documented in the subject's medical record). * Stable concomitant medication regimen for pulmonary health for at least 2 weeks prior to study drug administration

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. * Need for supplemental oxygen during the day, and \>2 L/minute while sleeping. * History of solid organ or hematopoietic cell transplantation. * 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. * Abnormal liver function test at screening, defined as aspartate aminotransferase (AST) and/or ALT and/or alkaline phosphatase and/or gamma-glutamyl transferase (GGT) ≥3x the upper limit of normal, and/or total bilirubin ≥1.5x the upper limit of normal.

Design outcomes

Primary

Measure	Time frame	Description
Maximum observed plasma concentration (cmax) of GLPG3067 single dose.	Between Day 1 pre-dose and Day 4.	To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Area under the plasma concentration-time curve from time zero until 24 hours post-dose ( (AUC0-24h) of GLPG3067 single dose.	Between Day 1 pre-dose and Day 4.	To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.
Area under the plasma concentration-time curve from time zero until 72 hours post-dose (AUC0-72h) of GLPG3067 single dose.	Between Day 1 pre-dose and Day 4.	To evaluate the PK profile of GLPG3067 after a single oral dose of GLPG3067.

Secondary

Measure	Time frame	Description
The number of subjects with adverse events.	From screening to 19 days after the last dose.	To evaluate the safety and tolerability of a single oral dose of GLPG3067 in adult male subjects with CF.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026