A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG3067 in Healthy Subjects.

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG3067/GLPG2222 Placebo multiple dose; Drug: GLPG3067 oral tablet; Drug: Placebo single dose; Drug: GLPG3067 single dose; Drug: GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose; Drug: GLPG3067/GLPG2222 multiple dose; Drug: GLPG3067/GLPG2222/GLPG2737 multiple dose; Drug: GLPG3067 oral suspension; Drug: GLPG3067 multiple dose; Drug: Placebo multiple dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT03128606

GLPG3067-CL-101

Details and patient eligibility

About

The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled, single center study, evaluating single and multiple ascending oral doses of GLPG3067 and the combination of GLPG3067 and GLPG2222 and the combination of GLPG3067,GLPG2222 and GLPG2737 given for 14 days in healthy women of non-childbearing potential.

The purpose of the study is to evaluate the safety and tolerability of single ascending oral doses and multiple ascending oral doses of GLPG3067 given to healthy women of non-childbearing potential compared to placebo, as well as of multiple oral doses of the combination of GLPG3067/GLPG2222 compared to matching placebo for each compound and multiple oral doses of the combination of GLPG3067/GLPG2222/GLPG2737 compared to matching placebo for each compound.

Enrollment: 81 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female subject between 18-70 years of age, inclusive, on the date of signing the informed consent form (ICF).
• 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 triplicate electrocardiogram (ECG), and clinical safety laboratory tests prior to the initial study drug administration.
• Discontinuation of all medications (including over-the-counter and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy for postmenopausal subjects) 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.

Exclusion 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 before screening.
• Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
• Any laboratory result considered by the investigator as clinically significant prior to study drug administration.
• 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.
• Clinically significant abnormalities of vital signs at screening.
• Clinically relevant abnormalities detected on ECG regarding either rhythm or conduction (e.g. QT interval corrected for heart rate using Fridericia's formula [QTcF] >470 ms) or a known long QT syndrome. A first degree heart block or sinus arrhythmia will not be considered as a significant abnormality.
• 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 initial study drug administration. Subjects who have been dosed previously with GLPG3067 in a clinical trial are allowed to participate Part 4 of this study as long as they completed their last follow-up visit or a washout period of 5 times the half-life of GLPG3067 (whichever is longer) after the last study drug administration is respected.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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81 participants in 13 patient groups, including a placebo group

GLPG3067 single dose

Experimental group

Description:

Single dose of GLPG3067 oral suspension at up to 6 dose levels in ascending order.

Treatment:

Drug: GLPG3067 single dose

Placebo single dose

Placebo Comparator group

Description:

Single dose of Placebo oral suspension.

Treatment:

Drug: Placebo single dose

GLPG3067 oral suspension fed 1

Experimental group

Description:

Single dose 1 of GLPG3067 oral suspension after a standardized breakfast.

Treatment:

Drug: GLPG3067 oral suspension

GLPG3067 oral tablet fed 1

Experimental group

Description:

Single dose 1 of GLPG3067 oral tablet after a standardized breakfast.

Treatment:

Drug: GLPG3067 oral tablet

GLPG3067 oral tablet fasted 1

Experimental group

Description:

Single dose 1 of GLPG3067 oral tablet after an overnight fast.

Treatment:

Drug: GLPG3067 oral tablet

GLPG3067 oral tablet fed 2

Experimental group

Description:

Single dose 2 of GLPG3067 oral tablet after a standardized breakfast.

Treatment:

Drug: GLPG3067 oral tablet

GLPG3067 oral tablet fed 2 high-fat high-calorie

Experimental group

Description:

Single dose 2 of GLPG3067 oral tablet after a high-fat high-calorie breakfast

Treatment:

Drug: GLPG3067 oral tablet

GLPG3067 multiple dose

Experimental group

Description:

Multiple doses of GLPG3067 oral suspension at up to 5 dose levels in ascending order.

Treatment:

Drug: GLPG3067 multiple dose

Placebo multiple dose

Placebo Comparator group

Description:

Multiple doses of Placebo oral suspension.

Treatment:

Drug: Placebo multiple dose

GLPG3067/GLPG2222 multiple dose

Experimental group

Description:

Multiple doses of GLPG3067 oral suspension combined with GLPG2222 oral tablet up to 2 dose levels in ascending order.

Treatment:

Drug: GLPG3067/GLPG2222 multiple dose

GLPG3067/GLPG2222 Placebo multiple dose

Placebo Comparator group

Description:

Multiple doses of GLPG3067 matching placebo oral suspension combined with GLPG2222 matching placebo oral tablet.

Treatment:

Drug: GLPG3067/GLPG2222 Placebo multiple dose

GLPG3067/GLPG2222/GLPG2737 multiple dose

Experimental group

Description:

Multiple doses of GLPG3067 oral tablet combined with GLPG2222 oral tablet and GLPG2737 oral capsule at up to 2 dose levels in ascending order.

Treatment:

Drug: GLPG3067/GLPG2222/GLPG2737 multiple dose

GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose

Placebo Comparator group

Description:

Multiple doses of GLPG3067 matching placebo oral tablet combined with GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule.

Treatment:

Drug: GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose