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.

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Drug: GLPG3067 single dose

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • University Hospital Leuven,Pediatric Pulmonology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GLPG3067 single dose.; Single Dose of GLPG3067 film coated tablets.	Drug: GLPG3067 single dose; GLPG3067 film coated tablets provided at Day 1.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Galapagos NV

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2018
• Primary Completion (ACTUAL): March 26, 2018
• Study Completion (ACTUAL): March 26, 2018

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (ACTUAL): July 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: GLPG3067-CL-104; 2017-002294-19 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No