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

NCT03128606 | Completed Phase 1

• 1 other identifier: GLPG3067-CL-101
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change versus placebo in the proportion of subjects with adverse events

  To assess safety and tolerability of single ascending doses, multiple ascending doses of GLPG3067 alone, or in combination with GLPG2222, or in combination with GLPG2222 and GLPG2737 versus placebo in healthy subjects

  Between screening and 14 days after the last dose

Secondary Outcomes (9)

• Maximum observed plasma concentration of GLPG3067 (Cmax) given alone or in combination with GLPG2222 or in combination with GLPG2222 and GLPG2737

  Between Day 1 predose and 10 days after the last dose

• Area under the plasma concentration-time curve of GLPG3067 (AUC0-t) given alone or in combination with GLPG2222 or in combination with GLPG2222 and GLPG2737

  Between Day 1 predose and 10 days after the last dose

• Ratio of 4-beta-hydroxycholesterol/cholesterol in plasma after multiple oral doses in healthy subjects

  Day 1 predose and Day 14

• Maximum observed plasma concentration of GLPG3067 (Cmax) given alone in fed state

  Between Day 1 predose and 10 days after the last dose

• Concentration in plasma observed at 24 hours post dose (C24h) of GLPG3067 given alone in fed state

  Between Day 1 predose and 10 days after the last dose

Study Arms (13)

GLPG3067 single dose

EXPERIMENTAL

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

Drug: GLPG3067 single dose

Placebo single dose

PLACEBO COMPARATOR

Single dose of Placebo oral suspension.

Drug: Placebo single dose

GLPG3067 oral suspension fed 1

EXPERIMENTAL

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

Drug: GLPG3067 oral suspension

GLPG3067 oral tablet fed 1

EXPERIMENTAL

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

Drug: GLPG3067 oral tablet

GLPG3067 oral tablet fasted 1

EXPERIMENTAL

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

Drug: GLPG3067 oral tablet

GLPG3067 oral tablet fed 2

EXPERIMENTAL

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

Drug: GLPG3067 oral tablet

GLPG3067 oral tablet fed 2 high-fat high-calorie

EXPERIMENTAL

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

Drug: GLPG3067 oral tablet

GLPG3067 multiple dose

EXPERIMENTAL

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

Drug: GLPG3067 multiple dose

Placebo multiple dose

PLACEBO COMPARATOR

Multiple doses of Placebo oral suspension.

Drug: Placebo multiple dose

GLPG3067/GLPG2222 multiple dose

EXPERIMENTAL

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

Drug: GLPG3067/GLPG2222 multiple dose

GLPG3067/GLPG2222 Placebo multiple dose

PLACEBO COMPARATOR

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

Drug: GLPG3067/GLPG2222 Placebo multiple dose

GLPG3067/GLPG2222/GLPG2737 multiple dose

EXPERIMENTAL

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

Drug: GLPG3067/GLPG2222/GLPG2737 multiple dose

GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose

PLACEBO COMPARATOR

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

Drug: GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose

Interventions

GLPG3067 single dose DRUG

GLPG3067 oral suspension, single ascending doses, daily

GLPG3067 single dose

Placebo single dose DRUG

Placebo, oral suspension, daily

Placebo single dose

GLPG3067 multiple dose DRUG

GLPG3067 oral suspension, multiple ascending doses, daily for 14 days

GLPG3067 multiple dose

Placebo multiple dose DRUG

Placebo, oral suspension, daily for 14 days

Placebo multiple dose

GLPG3067 oral suspension DRUG

GLPG3067 oral suspension, single dose, daily

GLPG3067 oral suspension fed 1

GLPG3067 oral tablet DRUG

GLPG3067 oral tablet, single dose, daily

GLPG3067 oral tablet fasted 1; GLPG3067 oral tablet fed 1; GLPG3067 oral tablet fed 2; GLPG3067 oral tablet fed 2 high-fat high-calorie

GLPG3067/GLPG2222 multiple dose DRUG

GLPG3067 oral suspension and GLPG2222 oral tablet, multiple doses, daily for 14 days

GLPG3067/GLPG2222 multiple dose

GLPG3067/GLPG2222 Placebo multiple dose DRUG

GLPG3067 matching placebo oral suspension and GLPG2222 matching placebo oral tablet, multiple doses, daily for 14 days

GLPG3067/GLPG2222 Placebo multiple dose

GLPG3067/GLPG2222/GLPG2737 multiple dose DRUG

GLPG3067 oral tablet, GLPG2222 oral tablet and GLPG2737 oral capsule, multiple doses, daily for 14 days

GLPG3067/GLPG2222/GLPG2737 multiple dose

GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose DRUG

GLPG3067 matching placebo oral tablet, GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule, multiple doses, daily for 14 days

GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Belgium

Location

Study Officials

• Magdalena Petkova, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 25, 2017
• Study Start: March 28, 2017
• Primary Completion: February 20, 2018
• Study Completion: February 20, 2018
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

BE (1)