First-in-Human Single and Multiple Dose of GLPG1972

G

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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