First-in-Human Single and Multiple Dose of GLPG1972

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo single dose; Drug: Placebo multiple doses; Drug: GLPG1972 single ascending doses; Drug: GLPG1972 multiple ascending doses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02612246

GLPG1972-CL-101

2015-004156-21 (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 GLPG1972 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1972 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 GLPG1972 present in the blood and urine (pharmacokinetics) will be characterized.

The effect of food on the pharmacokinetics of GLPG1972 will also be evaluated. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG1972 will be explored as well.

During the course of the study after multiple oral dose administrations, the effect of GLPG1972 on biomarkers present in the blood (pharmacodynamics) will be characterized.

Enrollment: 41 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

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 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 should be used

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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41 participants in 4 patient groups, including a placebo group

GLPG1972 single dose

Experimental group

Description:

Single oral dose of GLPG1972 solution - ascending doses

Treatment:

Drug: GLPG1972 single ascending doses

Placebo single dose

Placebo Comparator group

Description:

Single oral dose of placebo solution

Treatment:

Drug: Placebo single dose

GLPG1972 multiple doses

Experimental group

Description:

Multiple oral doses of GLPG1972 solution - ascending doses

Treatment:

Drug: GLPG1972 multiple ascending doses

Placebo multiple doses

Placebo Comparator group

Description:

Multiple oral doses of placebo solution

Treatment:

Drug: Placebo multiple doses