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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) up to 30 days

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

Nasopharyngitis

Headache

Upper respiratory tract infection

Nausea

Bronchitis

Osteitis

Lumbar spinal stenosis

Abscess oral

Rheumatoid arthritis

Gallbladder empyema

Depression

Myocardial ischaemia

Anaemia

Vulval abscess

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

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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

22,911 Total Patients Enrolled

Galapagos Study DirectorStudy DirectorGalapagos NV

21 Previous Clinical Trials

13,114 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility age for this clinical research limited to those below 80 years?

"This clinical trial is recruiting adult participants aged between 18 and 55 years old."

Answered by AI

Has Treatment B been given the regulatory green light by the FDA?

"All available evidence suggests Treatment B is safe, thus giving it a score of 1. However, the limited data used to evaluate its efficacy and safety necessitates that this be tested in Phase 1 clinical trials."

Answered by AI

Who is eligible to partake in this research initiative?

"Those that wish to be selected for this clinical trial must demonstrate bioavailability and fall between ages 18-55. 12 individuals will eventually join the study in total."

Answered by AI

Is enrollment still ongoing for this research endeavor?

"According to information on clinicaltrials.gov, this trial is not taking applicants presently. The study was initially listed on September 1st 2023 and last updated 12 days later; however, there are 3 other studies that currently have open enrollment periods for prospective patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects

2023. "Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06043739.