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

NCT ID: NCT01130922

Last Updated: 2011-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-06-30

Brief 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.

Conditions

Gastric Bypass; Body Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moxifloxacin IV

Group Type: EXPERIMENTAL

moxifloxacin per IV

Intervention Type: DRUG

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

Moxifloxacin oral

Group Type: ACTIVE_COMPARATOR

moxifloxacin per os

Intervention Type: DRUG

oral administration of 400 mg moxifloxacin in a single dose

Interventions

moxifloxacin per IV

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

Intervention Type: DRUG

moxifloxacin per os

oral administration of 400 mg moxifloxacin in a single dose

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

University Ghent

Principal Investigators

Jan Van Bocxlaer, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

University Hospital Ghent

Ghent, , Belgium

Countries

Belgium

References

De Smet J, Colin P, De Paepe P, Ruige J, Batens H, Van Nieuwenhove Y, Vogelaers D, Blot S, Van Bocxlaer J, Van Bortel LM, Boussery K. Oral bioavailability of moxifloxacin after Roux-en-Y gastric bypass surgery. J Antimicrob Chemother. 2012 Jan;67(1):226-9. doi: 10.1093/jac/dkr436. Epub 2011 Oct 10.

Reference Type: DERIVED

PMID: 21987240 (View on PubMed)

Other Identifiers

2010/099

Identifier Type: -

Identifier Source: org_study_id