aston.martin schreef op 26 februari 2013 20:34:
Nieuwe fase 1 met 0634, deze keer in combinatie met Midazolam (voornamelijk gebruikt als slaapmiddel en kalmeermiddel)
A Phase I, Open Interaction Study Between GLPG0634 and Midazolam in Healthy Subjects
This study is currently recruiting participants.
Verified February 2013 by Galapagos NV
Sponsor:
Galapagos NV
Information provided by (Responsible Party):
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01798979
First received: February 24, 2013
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
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Purpose
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 Intervention Phase
Healthy
Drug: GLPG0634
Drug: Midazolam
Phase 1
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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
Resource links provided by NLM:
MedlinePlus related topics: Drug Reactions
Drug Information available for: Midazolam hydrochloride
U.S. FDA Resources
Further study details as provided by Galapagos NV:
Primary Outcome Measures:
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 ] [ Designated as safety issue: No ]
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:
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) ] [ Designated as safety issue: No ]
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
Number of adverse events [ Time Frame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) ] [ Designated as safety issue: Yes ]
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
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) ] [ Designated as safety issue: Yes ]
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
Changes in 12-lead ECG measures [ Time Frame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) ] [ Designated as safety issue: Yes ]
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
Changes in physical exam measures [ Time Frame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) ] [ Designated as safety issue: Yes ]
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
Changes in blood safety lab parameters [ Time Frame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) ] [ Designated as safety issue: Yes ]
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
Changes in urine safety lab parameters [ Time Frame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) ] [ Designated as safety issue: Yes ]
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
Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Eligibility
Ages Eligible for Study: 40 Years to 60 Years
Genders 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01798979
Locations
United States, Wisconsin
Covance Clinical Research Unit Recruiting
Madison, Wisconsin, United States, 53704
Contact: Nicholas Siebers, MD
nicholas.siebers@covance.com Principal Investigator: Nicholas Siebers, MD
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Frédéric Vanhoutte, MD Galapagos NV
More Information
No publications provided
Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01798979 History of Changes
Other Study ID Numbers: GLPG0634-CL-103
Study First Received: February 24, 2013
Last Updated: February 25, 2013
Health Authority: United States: Food and Drug Administration
Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
ClinicalTrials.gov processed this record on February 25, 2013