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

NCT02162355 | Completed Phase 1 DMC

• 2 other identifiers: GLPG0634-CL-1102013-004408-21
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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?: No

  Between Day 1 before dosing and Day 13 (72 hours after last dose)

Secondary Outcomes (1)

• The amount of GLPG0634 mechanism-of-action-related biomarkers in blood

  Between Day 1 before dosing and Day 11 (24 hours after last dose)

Study Arms (4)

GLPG0634 in Japanese subjects

EXPERIMENTAL

Per panel, 6 Japanese healthy subjects will receive one of the three doses (50 mg, 100 mg or 200 mg) of GLPG0634 as tablets once daily for 10 days

Drug: GLPG0634 50 mg; Drug: GLPG0634 100 mg; Drug: GLPG0634 200 mg

Placebo in Japanese healthy subjects

PLACEBO COMPARATOR

Per panel, 2 or 4 (last panel only) Japanese healthy subjects will receive placebo as tablets once daily for 10 days

Drug: Placebo

GLPG0634 in Caucasian subjects

EXPERIMENTAL

In the last panel, 6 Caucasian healthy subjects will receive one dose of GLPG0634 (200 mg) as tablets once daily for 10 days

Drug: GLPG0634 200 mg

Placebo in Caucasian healthy subjects

PLACEBO COMPARATOR

In the last panel, 4 Caucasian healthy subjects will receive receive placebo as tablets once daily for 10 days

Drug: Placebo

Interventions

GLPG0634 50 mg DRUG

2 tablets of 25 mg GLPG0634 once daily for 10 days

Also known as: 50 mg GLPG0634 as tablets

GLPG0634 in Japanese subjects

GLPG0634 100 mg DRUG

1 tablet of 100 mg GLPG0634 once daily for 10 days

Also known as: 100 mg GLPG0634 as tablets

GLPG0634 in Japanese subjects

GLPG0634 200 mg DRUG

2 tablets of 100 mg GLPG0634 once daily for 10 days

Also known as: 200 mg GLPG0634 as tablets

GLPG0634 in Caucasian subjects; GLPG0634 in Japanese subjects

Placebo DRUG

1 or 2 matching placebo tablets once daily for 10 days

Also known as: Placebo as matching tablets

Placebo in Caucasian healthy subjects; Placebo in Japanese healthy subjects

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Hammersmith Medicines Research (HMR)

London, United Kingdom

Location

MeSH Terms

Interventions

GLPG0634; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Pille Harrison, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 12, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

GB (1)