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

NCT01130922 | Completed Phase 4

• 1 other identifier: 2010/099
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Roux-and-Y gastric bypass surgery; stable body weight

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Moxifloxacin IV

EXPERIMENTAL

Drug: moxifloxacin per IV

Moxifloxacin oral

ACTIVE COMPARATOR

Drug: moxifloxacin per os

Interventions

moxifloxacin per IV DRUG

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

Moxifloxacin IV

moxifloxacin per os DRUG

oral administration of 400 mg moxifloxacin in a single dose

Moxifloxacin oral

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Publications (1)

• 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.

  PMID: 21987240 DERIVED

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Van Bocxlaer, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: May 26, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 18, 2011

Record last verified: 2011-04

Locations

BE (1)