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Completed

NCT Number: NCT01798979

A Phase I, Open Interaction Study Between GLPG0634 and Midazolam in Healthy Subjects

This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG0634 on the single dose pharmacokinetic profile of midazolam administered in fasted normal healthy males. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG0634 and on Day 8, after multiple oral doses of GLPG0634 (daily for 7 days).

Also, the safety and tolerability of multiple oral doses of GLPG0634 co-administered with midazolam in healthy male subjects will be evaluated.

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Key information

Conditions

Healthy

Age range

40 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • male, between 40 and 60 years of age, inclusive
  • within BMI range 18 to 30 kg/m2, inclusive

Exclusion criteria

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

Treatment and study plan

GLPG0634

Drug

Each subject will receive multiple oral doses of GLPG0634 (200 mg daily for 7 days) from Days 2 to 8.

midazolam

Drug

Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 8)

Primary outcomes

  1. The amount of (1'-OH) Midazolam in plasma over time before and after multiple oral doses of GLPG0634

    Time frame: Between predose and up to 24h postdose on Day 1 and Day 8

    To characterize the amount of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG0634 - pharmacokinetics (PK) - in healthy subjects

Secondary outcomes

  1. The amount of GLPG0634 and metabolite in plasma over time after multiple oral doses of GLPG0634 (and co-administration of Midazolam on Day 8)

    Time frame: Between predose (Day 2) and up to 96h after the last dose on Day 8 (on Day 12)

    To characterize the amount of GLPG0634 and metabolite in plasma over time after multiple doses of GLPG0634 (and co-administration of Midazolam on Day 8) - pharmacokinetics (PK) - in healthy subjects

  2. Number of adverse events

    Time frame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)

    To evaluate the safety and tolerability of GLPG0634 after multiple oral doses in healthy subjects with or without coadministration of Midazolam in terms of the number of adverse events reported

  3. Changes in vital signs as measured by pulse, supine blood pressure, oral temperature (and respiratory rate only 1 hour post Midazolam dosing)

    Time frame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)

    To evaluate the safety and tolerability of GLPG0634 after multiple oral doses in healthy subjects with or without coadministration of Midazolam in terms of changes in vital signs as measured by pulse, supine blood pressure, oral temperature (and respiratory rate) reported

  4. Changes in 12-lead ECG measures

    Time frame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)

    To evaluate the safety and tolerability of GLPG0634 after multiple oral doses in healthy 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 GLPG0634 (Day 15-18)

    To evaluate the safety and tolerability of GLPG0634 after multiple oral doses in healthy 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 GLPG0634 (Day 15-18)

    To evaluate the safety and tolerability of GLPG0634 after multiple oral doses in healthy 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 GLPG0634 (Day 15-18)

    To evaluate the safety and tolerability of GLPG0634 after multiple oral doses in healthy subjects with or without coadministration of Midazolam in terms of changes in urine safety lab parameters reported

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

A Phase I, Open Interaction Study Between Oral Doses of GLPG0634 (200 mg QD) and Single Oral Doses of Midazolam (2 mg) in Healthy Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 26, 2013
Registry last updated
May 7, 2013

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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