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

Primary Purpose

Gastric Bypass, Body Weight

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
moxifloxacin per IV
moxifloxacin per os
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Bypass focused on measuring Roux-and-Y gastric bypass surgery, stable body weight

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moxifloxacin IV

Moxifloxacin oral

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the pharmacokinetics of 400 mg moxifloxacin per IV compared to 400 mg moxifloxacin per os in patients who had a gastric bypass

Secondary Outcome Measures

Full Information

First Posted
April 22, 2010
Last Updated
April 15, 2011
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01130922
Brief Title
Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass
Acronym
DRUG10_MOXI
Official Title
Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Bypass, Body Weight
Keywords
Roux-and-Y gastric bypass surgery, stable body weight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moxifloxacin IV
Arm Type
Experimental
Arm Title
Moxifloxacin oral
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
moxifloxacin per IV
Intervention Description
intravenous administration of 400 mg moxifloxacin (as a 1h-infusion)
Intervention Type
Drug
Intervention Name(s)
moxifloxacin per os
Intervention Description
oral administration of 400 mg moxifloxacin in a single dose
Primary Outcome Measure Information:
Title
To evaluate the pharmacokinetics of 400 mg moxifloxacin per IV compared to 400 mg moxifloxacin per os in patients who had a gastric bypass
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Van Bocxlaer, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
21987240
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.
Results Reference
derived

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

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