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Completed

NCT Number: NCT02162355

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

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.

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Key information

Conditions

Healthy

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hammersmith Medicines Research (HMR)

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLPG0634 50 mg

Drug

2 tablets of 25 mg GLPG0634 once daily for 10 days

Other names: 50 mg GLPG0634 as tablets

GLPG0634 100 mg

Drug

1 tablet of 100 mg GLPG0634 once daily for 10 days

Other names: 100 mg GLPG0634 as tablets

GLPG0634 200 mg

Drug

2 tablets of 100 mg GLPG0634 once daily for 10 days

Other names: 200 mg GLPG0634 as tablets

Placebo

Drug

1 or 2 matching placebo tablets once daily for 10 days

Other names: Placebo as matching tablets

Primary outcomes

  1. The number of subjects with adverse events

    Time frame: From screening up to 10 days after last dose (Day 20)

    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)

  2. The number of subjects with abnormal laboratory parameters

    Time frame: From screening up to 10 days after last dose (Day 20)

    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

  3. The number of subjects with abnormal vital signs

    Time frame: From screening up to 10 days after last dose (Day 20)

    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

  4. The number of subjects with abnormal electrocardiogram

    Time frame: From screening up to 10 days after last dose (Day 20)

    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

  5. The number of subjects with abnormal physical examination

    Time frame: From screening up to 10 days after last dose (Day 20)

    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

  6. The amount of GLPG0634 and metabolite in plasma and urine

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

    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

Secondary outcomes

  1. The amount of GLPG0634 mechanism-of-action-related biomarkers in blood

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

    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

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 12, 2014
Registry last updated
Sep 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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