Cystic fibrosis Cystic fibrosis
Conditions
Interventions
Sponsors
Galapagos NV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Male between 18-50 years of age, inclusive, on the date of signing the Informed Consent Form (ICF). - A body mass index (BMI) between 18-30 kg/m2, inclusive. - Judged by the investigator to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and clinical safety laboratory tests prior to the initial study drug administration. Clinical safety laboratory test results must be within the laboratory reference ranges for males or test results that are outside the reference ranges for males need to be considered non clinically significant in the opinion of the investigator. One retest is allowed if deemed appropriate by the investigator without asking permission from the sponsor. - Discontinuation of all medications (including over-the-counter and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) least 2 weeks prior to the first study drug administration.;Reference is made to the protocol for a complete overview of the inclusion criteria.
Exclusion criteria
Exclusion criteria: * History of or a current immunosuppressive condition (e.g., human immunodeficiency virus [HIV] infection type 1 and 2). * Clinically significant illness in the 3 months before screening. * Presence or having sequelae of gastrointestinal, liver, kidney (creatinine clearance [CLCR] * 80 mL/min using the Cockcroft-Gault formula: if calculated result * 80 mL/min, a 24 hour urine collection to determine actual value can be done) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. * Treatment with any drug known to have a well-defined potential for toxicity to a major organ within the last 3 months or 5-half-lives of the drug (whichever is longer) before the initial drug administration. * Participation in a drug, drug and device delivery system or combination or biologic investigational research study within 8 weeks or 5 times the half-life of the investigational drug, if the half-life is known (whichever is longer) prior to screening.;Reference is made to the protocol for a complete overview of the exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Determine PK parameters of GLPG2737 in plasma after administration of a single dose of a suspension and of a capsule formulation in healthy subjects. - Determine safety and tolerability of GLPG2737 in healthy male subjects, as assessed by the number of subjects with adverse events (AEs). | — |
Countries
The Netherlands
Outcome results
None listed