Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass

Study Overview
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Brief Summary
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Roux-and-Y gastric bypass is one of the most common forms of bariatric surgery; due to a reduction in size of the stomach and intestine, the available surface area for the absorption of oral drugs is strongly decreased. This may lead to a reduced bioavailability resulting in a reduced efficacy of the drug. However, in literature there is no information available about the impact of bariatric surgery on the pharmacokinetics of moxifloxacin. This protocol evaluates the moxifloxacin plasma levels, the variability between subjects and the absolute bioavailability, after oral administration of 400 mg moxifloxacin in healthy volunteers who have had a gastric bypass at least 6 months ago and who now have a stable body weight.

Official Title
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Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass.

Conditions
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Gastric Bypass, Body Weight

Intervention / Treatment
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* Drug: moxifloxacin per IV
* Drug: moxifloxacin per os


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers who have had a gastric bypass at least 6 months ago and whose body weight has not changed more than 5% during the last 3 months Age between 18 and 60 years old Able to give informed consent Exclusion Criteria: Other forms of bariatric surgery (Scopinaro and Mason/Sleeve) before gastric bypass surgery Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients Pregnancy and lactation Creatinine clearance < 80 ml/min Transaminases > 2x the upper limit of normal (AST/ALT) Impaired liver function (Child Pugh C) Fasting glycaemia > 125mg/dl Epilepsy Patients with a history of tendon disease/disorder (especially Achilles tendon rupture) related to quinolone treatment Patients with the following heart disorders: Electrolyte disturbance, particularly an uncorrected hypokalaemia Clinically relevant bradycardia Clinically relevant heart failure with reduced left-ventricular ejection fraction Previous history of symptomatic arrhythmias Congenital or documented acquired QT prolongation or concurrently use of drugs that prolong the QT interval: anti-arrhythmics (Classes IA and III) neuroleptics tricyclic antidepressants antimicrobials (e.g. sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine) some antihistamines (e.g. terfenadine, astemizole, mizolastine) cisapride, intravenous vincamine, bepridil and diphemanil No normal thyroid function All clinically significant disorders that can interfere with the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxifloxacin IV<br> | Drug: moxifloxacin per IV<br>* intravenous administration of 400 mg moxifloxacin (as a 1h-infusion)<br>|
| Active Comparator: Moxifloxacin oral<br> | Drug: moxifloxacin per os<br>* oral administration of 400 mg moxifloxacin in a single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics of 400 mg moxifloxacin per IV compared to 400 mg moxifloxacin per os in patients who had a gastric bypass |  | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Roux-and-Y gastric bypass surgery, stable body weight