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

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ClinicalTrials.gov Identifier: NCT02562950
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : October 23, 2015
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: GLPG1837 500 mg Drug: Midazolam Drug: GLPG1837 1000 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open Interaction Study Between Oral Doses of GLPG1837 and Single Doses of Midazolam in Healthy Male Subjects
Study Start Date : September 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Midazolam and 500 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (250 mg b.i.d daily for 10 days) from Days 2 to 11.
Drug: GLPG1837 500 mg
Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12.

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

Experimental: Midazolam and 1000 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (500 mg b.i.d daily for 11 days) from Days 2 to 12.
Drug: Midazolam
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).

Drug: GLPG1837 1000 mg
Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562950


Locations
Belgium
SGS LSS Clinical Pharmacology Unit Antwerp
Antwerp, Belgium
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Frédéric Vanhoutte, MD Galapagos NV

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT02562950     History of Changes
Other Study ID Numbers: GLPG1837-CL-102
2015-002517-29 ( EudraCT Number )
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: October 23, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action