Clinical trial NCT01130922: Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass
Official title: Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Bypass
Body Weight
Keywords: Roux-and-Y gastric bypass surgery
stable body weight
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2010-05-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To evaluate the pharmacokinetics of 400 mg moxifloxacin per IV compared to 400 mg moxifloxacin per os in patients who had a gastric bypass
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Ghent
name: Jan Van Bocxlaer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.