A Phase I, open-label study to investigate the pharmacokinetics of GLPG2451 given as two doses of a capsule formulation in healthy subjects
- Conditions
- Cystic fibrosismucoviscidosisthick mucus disease10027664
- Registration Number
- NL-OMON45502
- Lead Sponsor
- Galapagos SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 12
- Male subject or female subject of non-childbearing potential between 18-50 years of age, inclusive, on the date of signing the informed consent form (ICF).
- Female subjects must be 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]).
- Have a body mass index 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, or test results that are outside the reference ranges need to be considered non-clinically significant in the opinion of the investigator. One retest is allowed if deemed appropriate by the investigator.
- 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) at least 2 weeks prior to the first study drug administration.
- Able and willing to comply with the prohibitions and restrictions and with the contraceptive requirements (male subjects only), as described
in the protocol.
- Able and willing to sign the ICF as approved by the Independent Ethics Committee (IEC), prior to any screening evaluations.;Reference is made to the protocol for a complete overview of the inclusion criteria.
- Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the investigator, such as
anaphylaxis requiring hospitalization.
- Clinically significant symptoms or illness in the 3 months prior to screening.
- Presence or having sequelae of gastrointestinal, liver, kidney or other conditions known to interfere with the absorption, distribution,
metabolism, or excretion of drugs.
- Evidence of lens opacity on slit lamp examination or similar system.
- Significant blood loss (including blood donation [>500 mL]), or a transfusion of any blood product within 12 weeks prior to the first study
drug administration.
- 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) prior to the first study 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 the first 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>- Determine PK parameters of GLPG2451 in plasma (including Cmax, AUC)<br /><br>administered as two doses of a capsule formulation in healthy subjects.<br /><br>- Determine safety and tolerability of GLPG2451 in healthy subjects, assessed<br /><br>by the number of subjects with AEs.</p><br>
- Secondary Outcome Measures
Name Time Method <p>SECONDARY ENDPOINT<br /><br>- Determine PK parameters of G1171564 (metabolite of GLPG2451) in plasma.</p><br>