Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2018-03-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GLPG3067 single dose.

Single Dose of GLPG3067 film coated tablets.

Group Type EXPERIMENTAL

GLPG3067 single dose

Intervention Type DRUG

GLPG3067 film coated tablets provided at Day 1.

Interventions

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GLPG3067 single dose

GLPG3067 film coated tablets provided at Day 1.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No