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Treatment B: for Bioavailability

Phase 1
Waitlist Available
Research Sponsored by Galapagos NV
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) up to 30 days
Awards & highlights

Study Summary

This trial will compare the effectiveness of two forms of a medication and how food affects one of them.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) up to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) up to 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC0-inf of GS-829845, major active metabolite
AUC0-t of GS-829845, major active metabolite
Area under the plasma concentration time curve from time zero to infinity of filgotinib (AUC0-inf)
+3 more
Secondary outcome measures
Number of participants with treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations

Side effects data

From 2018 Phase 3 trial • 449 Patients • NCT02873936
6%
Nasopharyngitis
6%
Headache
6%
Upper respiratory tract infection
5%
Nausea
2%
Bronchitis
1%
Abscess oral
1%
Rheumatoid arthritis
1%
Lumbar spinal stenosis
1%
Osteitis
1%
Gallbladder empyema
1%
Depression
1%
Myocardial ischaemia
1%
Anaemia
1%
Vulval abscess
100%
80%
60%
40%
20%
0%
Study treatment Arm
Filgotinib 100 mg
Placebo
Filgotinib 200 mg

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Treatment C:Experimental Treatment1 Intervention
filgotinib administered under high-fat fed conditions
Group II: Treatment B:Experimental Treatment1 Intervention
filgotinib administered under fasting conditions
Group III: Treatment A:Active Control1 Intervention
filgotinib administered under fasting conditions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgotinib
2017
Completed Phase 3
~7520

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Galapagos NVLead Sponsor
137 Previous Clinical Trials
22,739 Total Patients Enrolled
Galapagos Study DirectorStudy DirectorGalapagos NV
21 Previous Clinical Trials
12,942 Total Patients Enrolled
~7 spots leftby Jun 2025
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