Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.

NCT03589313 | Completed Phase 1

• 2 other identifiers: GLPG3067-CL-1042017-002294-19
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• The number of subjects with adverse events.

  From screening to 19 days after the last dose.

Study Arms (1)

GLPG3067 single dose.

EXPERIMENTAL

Single Dose of GLPG3067 film coated tablets.

Drug: GLPG3067 single dose

Interventions

GLPG3067 single dose DRUG

GLPG3067 film coated tablets provided at Day 1.

GLPG3067 single dose.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

University Hospital Leuven,Pediatric Pulmonology

Leuven, Belgium

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Olivier Van de Steen, MD MBA

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 17, 2018
• Study Start: February 12, 2018
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

BE (1)