Clinical trial NCT02162355: Multiple Ascending Dose Study of GLPG0634 in Japanese and Caucasian Healthy Subjects
Official title: Randomized, Double-blind, Placebo-controlled Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, of Multiple Oral Doses of GLPG0634 in Japanese and Caucasian Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2014-06-12
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this multiple ascending dose study is to characterize the safety, tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics) of once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in Japanese healthy subjects.

Furthermore, the study will compare the safety, tolerability, pharmacokinetics, and effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) of once daily oral administrations of GLPG0634 given at one dose level for 10 days in Japanese vs Caucasian healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Male or female Japanese or Caucasian subjects between 20-65 years of age (included)
* Subjects must have a body mass index between 18-28 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 profile

Exclusion Criteria:

* A subject with a known hypersensitivity to ingredients of the study drug or a significant allergic reaction to any drug
* Concurrent participation or participation within 3 months 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
* Subject expresses current desire to have (more) children
* Female subject is less than 6 months post-partum, post-abortion or post lactation prior to study drug administration or is pregnant or breastfeeding

Primary outcomes:
measure: The number of subjects with adverse events
timeFrame: From screening up to 10 days after last dose (Day 20)
measure: The number of subjects with abnormal laboratory parameters
timeFrame: From screening up to 10 days after last dose (Day 20)
measure: The number of subjects with abnormal vital signs
timeFrame: From screening up to 10 days after last dose (Day 20)
measure: The number of subjects with abnormal electrocardiogram
timeFrame: From screening up to 10 days after last dose (Day 20)
measure: The number of subjects with abnormal physical examination
timeFrame: From screening up to 10 days after last dose (Day 20)
measure: The amount of GLPG0634 and metabolite in plasma and urine
timeFrame: Between Day 1 before dosing and Day 13 (72 hours after last dose)
Secondary outcomes:
measure: The amount of GLPG0634 mechanism-of-action-related biomarkers in blood
timeFrame: Between Day 1 before dosing and Day 11 (24 hours after last dose)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research (HMR)
Study officials:
affiliation: Galapagos NV
name: Pille Harrison, MD
role: STUDY_DIRECTOR
References: