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Completed

NCT Number: NCT02143856

Oral Bioavailability of Solid Formulation of GLPG1205 With and Without Food

The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single oral administration of GLPG1205 given as a capsule formulation in fasted versus fed conditions in male healthy subjects.

Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule formulation under fasted and fed conditions will be assessed.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male, age 18-50 years
  • BMI between 18-30 kg/m2

Exclusion criteria

  • Any condition that might interfere with the procedures or tests in this study
  • Drug or alcohol abuse
  • Smoking

Treatment and study plan

100 mg GLPG1205

Drug

A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg

Primary outcomes

  1. The amount of GLPG1205 in plasma

    Time frame: From predose up to 504 hours (Day 22) after study drug administration

    To characterize and compare the amount of GLPG1205 in plasma ( relative bioavailability) in male healthy subjects after a single administration of a capsule formulation in a fasted versus fed condition.

Secondary outcomes

  1. The number of subjects with adverse events

    Time frame: From screening up to 28 (+/-2) days after last study drug administration

    To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of adverse events (AEs)

  2. The number of subjects with abnormal laboratory parameters

    Time frame: From screening up to 28 (+/-2) days after last study drug administration

    To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal laboratory parameters

  3. The number of subjects with abnormal vital signs

    Time frame: From screening up to 28 (+/-2) days after last study drug administration

    To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal vital signs

  4. The number of subjects with abnormal electrocardiogram (ECG)

    Time frame: From screening up to 28 (+/-2) days after last study drug administration

    To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal electrocardiogram (ECG)

  5. The number of subjects with abnormal physical examination

    Time frame: From screening up to 28 (+/-2) days after last study drug administration

    To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal physical examination

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

A Randomized, Open-label, Two-way Cross-over Study to Determine the Oral Bioavailability of GLPG1205 After Single-dose Intake in Healthy Male Subjects as a Solid Formulation, With and Without Food

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 21, 2014
Registry last updated
Jul 22, 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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