Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass
Information source: University Ghent
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastric Bypass; Body Weight
Intervention: moxifloxacin per IV (Drug); moxifloxacin per os (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University Ghent Official(s) and/or principal investigator(s): Jan Van Bocxlaer, PhD, Principal Investigator, Affiliation: University Ghent
Summary
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.
Clinical Details
Official title: Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass.
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate the pharmacokinetics of 400 mg moxifloxacin per IV compared to 400 mg moxifloxacin per os in patients who had a gastric bypass
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University Hospital Ghent, Ghent, Belgium
Additional Information
Starting date: March 2010
Last updated: April 15, 2011
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