- To evaluate the pharmacokinetic (PK) profile of the combination of GLPG3067, GLPG2222, and GLPG2737 following repeated morning versus evening doses given to healthy female subjects - To evaluate the safety and tolerability of the combination of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Cystische Fibrose
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PK parameters (including AUCtau, Cmax, and C24h) of GLPG3067, GLPG2222, and
GLPG2737 in plasma following combined administration of GLPG3067, GLPG2222, and
GLPG2737.
Secondary outcome
Determine safety and tolerability of the combination of GLPG3067, GLPG2222, and
GLPG2737 in healthy adult female subjects, assessed by the number of subjects
with AEs.
Background summary
Cystic fibrosis (CF) is an autosomal recessive genetic disease caused by
mutations in the gene encoding for the cystic fibrosis transmembrane
conductance regulator (CFTR) protein. CFTR dysfunction results in viscid
secretions that are difficult to clear, affecting most exocrine glands, notably
the pancreas, intestine, liver, and bile duct. However, most morbidity and
mortality results from dehydration of the airway surface liquid and impaired
airway mucociliary clearance, which leads to cycles of bacterial infection,
chronic inflammation, bronchiectasis and progressive decline in pulmonary
function. GLPG has set up a development program that aims to effectively treat
CF by developing a combination therapy composed of multiple CFTR modulators
with complementary mode of action.
For further information, reference is made to the introduction of the protocol.
Study objective
- To evaluate the pharmacokinetic (PK) profile of the combination of GLPG3067,
GLPG2222, and GLPG2737 following repeated morning versus evening doses given to
healthy female subjects
- To evaluate the safety and tolerability of the combination of GLPG3067,
GLPG2222, and GLPG2737 given to healthy female subjects
Study design
This study will be performed in up to 10 healthy volunteers.
The study will consist of 2 treatment periods during which the volunteer will
receive a combination of GLPG3067, GLPG2222 and GLPG2737 as multiple doses for
7 days in the morning in one treatment period and as multiple doses for 7 days
in the evening in the other treatment period. GLPG3067, GLPG2222 and GLPG2737
will be given as oral tablets (GLPG3067 and GLPG2222) or oral capsules
(GLPG2737) with 240 mL of water.
For further information, reference is made to the protocol.
Intervention
n.a.
Study burden and risks
There is no direct benefit for the subjects from taking part in the study. The
results of the study will provide valuable information for future research. Not
all side effects of new compounds, such as GLPG3067, GLPG2222 and GPLG2737 are
known. Unexpected side effects might occur.
Generaal De Wittelaan L11 A3
Mechelen 2800
BE
Generaal De Wittelaan L11 A3
Mechelen 2800
BE
Listed location countries
Age
Inclusion criteria
- 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.
Exclusion 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-004507-44-NL |
| CCMO | NL64055.056.17 |