Multiple Ascending Dose Study of GLPG0634 in Japanese and Caucasian Healthy Subjects

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162355
• Other study ID #: GLPG0634-CL-110
• Secondary ID: 2013-004408-21
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2014
• Last updated: September 14, 2014
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG0634 50 mg
2 tablets of 25 mg GLPG0634 once daily for 10 days
• GLPG0634 100 mg
1 tablet of 100 mg GLPG0634 once daily for 10 days
• GLPG0634 200 mg
2 tablets of 100 mg GLPG0634 once daily for 10 days
• Placebo
1 or 2 matching placebo tablets once daily for 10 days

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research (HMR)	London

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of subjects with adverse events	To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of adverse events (AEs)	From screening up to 10 days after last dose (Day 20)	Yes
Primary	The number of subjects with abnormal laboratory parameters	To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal laboratory parameters	From screening up to 10 days after last dose (Day 20)	Yes
Primary	The number of subjects with abnormal vital signs	To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal vital signs	From screening up to 10 days after last dose (Day 20)	Yes
Primary	The number of subjects with abnormal electrocardiogram	To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal electrocardiogram	From screening up to 10 days after last dose (Day 20)	Yes
Primary	The number of subjects with abnormal physical examination	To evaluate the safety and tolerability of GLPG0634 versus placebo in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested in terms of abnormal physical examination	From screening up to 10 days after last dose (Day 20)	Yes
Primary	The amount of GLPG0634 and metabolite in plasma and urine	To characterize the amount of GLPG0634 and metabolite in plasma and urine over time - pharmacokinetics (PK) - in Japanese subjects at different dose levels, and between Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested; Safety Issue?:	Between Day 1 before dosing and Day 13 (72 hours after last dose)	No
Secondary	The amount of GLPG0634 mechanism-of-action-related biomarkers in blood	To characterize the effects of GLPG0634 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - in Japanese and Caucasian subjects at the highest dose level of GLPG0634 tested	Between Day 1 before dosing and Day 11 (24 hours after last dose)	No