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Completed

NCT Number: NCT02562950

A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects

This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with GLPG1837, after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day 11).

Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with midazolam in healthy male subjects will be evaluated.

A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.) GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg (500 mg b.i.d.) GLPG1837.

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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

GLPG1837 500 mg

Drug

Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12.

midazolam

Drug

Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).

GLPG1837 1000 mg

Drug

Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12.

Primary outcomes

  1. The maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837

    Time frame: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)

    To characterize the maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG1837 in healthy male subjects

  2. The time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837

    Time frame: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)

    To characterize the time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects

  3. The area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple oral doses of GLPG1837

    Time frame: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)

    To characterize the area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple doses of GLPG1837 in healthy male subjects

  4. The apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837

    Time frame: Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)

    To characterize the apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects

Secondary outcomes

  1. The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)

    Time frame: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)

    To characterize the maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects

  2. Number of adverse events

    Time frame: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12

    To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of the number of adverse events reported

  3. Changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature

    Time frame: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12

    To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature reported

  4. Changes in 12-lead ECG measures

    Time frame: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12

    To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in 12-ECG measures reported

  5. Changes in physical exam measures

    Time frame: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12

    To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in physical examination reported

  6. Changes in blood safety lab parameters

    Time frame: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12

    To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in blood safety lab parameters reported

  7. Changes in urine safety lab parameters

    Time frame: Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12

    To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in urine safety lab parameters reported

  8. The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)

    Time frame: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)

    To characterize the time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects

  9. The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)

    Time frame: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)

    To characterize the area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects

  10. The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)

    Time frame: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)

    To characterize the apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects

  11. The metabolite to GLPG1837 ratios in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)

    Time frame: Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)

    To characterize the metabolite to GLPG1837 ratios in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

A Phase I, Open Interaction Study Between Oral Doses of GLPG1837 and Single Doses of Midazolam in Healthy Male Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 29, 2015
Registry last updated
Oct 23, 2015

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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