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Trial record 5 of 34 for:    GLPG0634

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

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ClinicalTrials.gov Identifier: NCT01798979
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : May 7, 2013
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 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.


Condition or disease Intervention/treatment Phase
Healthy Drug: GLPG0634 Drug: Midazolam Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Midazolam and GLPG0634
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 8) and multiple oral doses of GLPG0634 (200 mg daily for 7 days) from Days 2 to 8.
Drug: GLPG0634
Each subject will receive multiple oral doses of GLPG0634 (200 mg daily for 7 days) from Days 2 to 8.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01798979


Locations
United States, Wisconsin
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Frédéric Vanhoutte, MD Galapagos NV

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01798979     History of Changes
Other Study ID Numbers: GLPG0634-CL-103
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: May 2013

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