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

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.

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Key information

Conditions

Gastric Bypass Body Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Ghent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

moxifloxacin per IV

Drug

intravenous administration of 400 mg moxifloxacin (as a 1h-infusion)

moxifloxacin per os

Drug

oral administration of 400 mg moxifloxacin in a single dose

Primary outcomes

To evaluate the pharmacokinetics of 400 mg moxifloxacin per IV compared to 400 mg moxifloxacin per os in patients who had a gastric bypass

Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Acronym: DRUG10_MOXI

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: May 26, 2010
Registry last updated: Apr 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed