First-in-Human Single and Multiple Dose of GLPG1837

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG1837 single ascending doses; Drug: Placebo multiple doses; Drug: GLPG1837 multiple ascending doses; Drug: Placebo single dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02325037

GLPG1837-CL-101

2014-003853-32 (EudraCT Number)

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 GLPG1837 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy subjects daily for 14 days compared to placebo, will be evaluated.

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1837 and its metabolite present in the blood and urine (pharmacokinetics) will be characterized.

The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be evaluated.

The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will be explored as well.

Enrollment: 64 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males or females of non-child bearing potential between 18-50 years of age (included)
• Subjects must have a body mass index between 18-30 kg/m² (included)
• 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 findings

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 or participation within 15 weeks prior to initial study drug administration in an investigational research study with antibody administration
• 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 should be used
• Pregnant or lactating women or women of childbearing potential

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 4 patient groups, including a placebo group

GLPG1837 single dose

Experimental group

Description:

Single oral dose of GLPG1837 suspension - ascending doses

Treatment:

Drug: GLPG1837 single ascending doses

Placebo single dose

Placebo Comparator group

Description:

Single oral dose of placebo suspension

Treatment:

Drug: Placebo single dose

GLPG1837 muliple doses

Experimental group

Description:

Multiple oral doses of GLPG1837 suspension - ascending doses

Treatment:

Drug: GLPG1837 multiple ascending doses

Placebo multiple doses

Placebo Comparator group

Description:

Multiple oral doses of placebo suspension

Treatment:

Drug: Placebo multiple doses