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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GLPG0634; Drug: Midazolam

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of (1'-OH) Midazolam in plasma over time before and after multiple oral doses of GLPG0634	To characterize the amount of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG0634 - pharmacokinetics (PK) - in healthy subjects	Between predose and up to 24h postdose on Day 1 and Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of GLPG0634 and metabolite in plasma over time after multiple oral doses of GLPG0634 (and co-administration of Midazolam on Day 8)	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	Between predose (Day 2) and up to 96h after the last dose on Day 8 (on Day 12)
Number of adverse events	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	Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)
Changes in vital signs as measured by pulse, supine blood pressure, oral temperature (and respiratory rate only 1 hour post Midazolam dosing)	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	Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)
Changes in 12-lead ECG measures	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	Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)
Changes in physical exam measures	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	Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)
Changes in blood safety lab parameters	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	Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)
Changes in urine safety lab parameters	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	Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)

Collaborators and Investigators

• Sponsor: Galapagos NV

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: February 24, 2013
• First Submitted That Met QC Criteria: February 25, 2013
• First Posted (Estimate): February 26, 2013

Study Record Updates

• Last Update Posted (Estimate): May 7, 2013
• Last Update Submitted That Met QC Criteria: May 5, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: GLPG0634-CL-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No