First-in-Human Single and Multiple Dose of GLPG2222

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo multiple doses; Drug: GLPG2222 multiple doses; Drug: GLPG2222 single dose; Drug: Placebo single dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02662452

2015-004466-29 (EudraCT Number)

GLPG2222-CL-101

Details and patient eligibility

About

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2).

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized.

The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males between 18-50 years of age
• Subjects must have a body mass index between 18-30 kg/m²
• Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile
• Subjects must have a screening spirometry with forced expiratory volume in 1 second ≥80% of predicted values for age, gender and height (Part 1 only)

Exclusion criteria

• A subject with a known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
• Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study
• A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
• Current sexually active (and/or child wish) male; a contraception method must be used

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups, including a placebo group

GLPG2222 single dose

Experimental group

Description:

Single dose of GLPG2222 oral suspension

Treatment:

Drug: GLPG2222 single dose

Placebo single dose

Placebo Comparator group

Description:

Single dose of placebo oral suspension

Treatment:

Drug: Placebo single dose

GLPG2222 multiple doses

Experimental group

Description:

Multiple doses of GLPG2222 oral suspension

Treatment:

Drug: GLPG2222 multiple doses

Placebo multiple doses

Placebo Comparator group

Description:

Multiple doses of placebo oral suspension

Treatment:

Drug: Placebo multiple doses