A Phase I, open-label, randomized, two-way crossover study to investigate the effects of morning versus evening repeated dosing on the pharmacokinetics of the combination of GLPG3067, GLPG2222 and GLPG2737 in healthy female subjects.
- Conditions
- Cystische FibroseCystic FibrosisMucoviscidosis
- Registration Number
- NL-OMON44378
- Lead Sponsor
- Galapagos N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
- Female subject between 18-70 years of age, inclusive, on the date of signing the informed consent form (ICF).
- Being of non-childbearing potential, defined as surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy), or post-menopausal (at least 12 consecutive months without menstruation, without an alternative medical cause [including hormone replacement therapy]). In addition, a determination of follicle stimulating hormone (FSH) must be performed with FSH >35 mIU/mL to further confirm postmenopausal status without menstruation for >12 months. Subjects must have a negative serum pregnancy test. For surgical sterilization, documented confirmation will be requested.
- Having 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 triplicate 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 women, or test results that are outside the reference ranges for women need to be considered non-clinically significant in the opinion of the investigator.;Reference is made to the protocol for a complete overview of the inclusion criteria.
- Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Creatinine clearance <=80 mL/min using the Cockcroft-Gault formula for subjects aged <=50 years, or creatinine clearance <=70 mL/min using the Cockcroft-Gault formula for subjects aged >50 years. A 24-hour urine collection to determine the actual value may be performed to confirm creatinine clearance if required.
- Treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months or 5 times the half-life of the drug (whichever is longer) before the initial study drug administration.
- Participation in a drug, drug and device delivery system or combination, or biological 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 initial study drug administration. ;Reference is made to the protocol for a complete overview of the exclusion criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PK parameters (including AUCtau, Cmax, and C24h) of GLPG3067, GLPG2222, and<br /><br>GLPG2737 in plasma following combined administration of GLPG3067, GLPG2222, and<br /><br>GLPG2737.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Determine safety and tolerability of the combination of GLPG3067, GLPG2222, and<br /><br>GLPG2737 in healthy adult female subjects, assessed by the number of subjects<br /><br>with AEs.</p><br>