Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass (DRUG10_MOXI)

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.

Study Overview

• Status: Completed
• Conditions: Body Weight; Gastric Bypass
• Intervention / Treatment: Drug: moxifloxacin per IV; Drug: moxifloxacin per os

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Moxifloxacin IV	Drug: moxifloxacin per IV; intravenous administration of 400 mg moxifloxacin (as a 1h-infusion)
ACTIVE_COMPARATOR: Moxifloxacin oral	Drug: moxifloxacin per os; oral administration of 400 mg moxifloxacin in a single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Ghent

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: April 22, 2010
• First Submitted That Met QC Criteria: May 25, 2010
• First Posted (ESTIMATE): May 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 18, 2011
• Last Update Submitted That Met QC Criteria: April 15, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Roux-and-Y gastric bypass surgery; stable body weight
• Additional Relevant MeSH Terms: Body Weight; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
• Other Study ID Numbers: 2010/099