Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03589313 |
Date of registration:
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09/07/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis.
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Scientific title:
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Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG3067 Administered as Solid Formulation in Male Subjects With Cystic Fibrosis. |
Date of first enrolment:
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February 12, 2018 |
Target sample size:
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6 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03589313 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Olivier Van de Steen, MD MBA |
Address:
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Telephone:
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Email:
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Affiliation:
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Galapagos NV |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: GLPG3067 single dose
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Primary Outcome(s)
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Maximum observed plasma concentration (cmax) of GLPG3067 single dose.
[Time Frame: Between Day 1 pre-dose and Day 4.]
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Area under the plasma concentration-time curve from time zero until 72 hours post-dose (AUC0-72h) of GLPG3067 single dose.
[Time Frame: Between Day 1 pre-dose and Day 4.]
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Area under the plasma concentration-time curve from time zero until 24 hours post-dose ( (AUC0-24h) of GLPG3067 single dose.
[Time Frame: Between Day 1 pre-dose and Day 4.]
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Secondary Outcome(s)
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The number of subjects with adverse events.
[Time Frame: From screening to 19 days after the last dose.]
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Secondary ID(s)
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2017-002294-19
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GLPG3067-CL-104
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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