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

Sponsor
University Ghent (Other)
Overall Status
Completed
CT.gov ID
NCT01130922
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
3
Duration (Months)
4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: moxifloxacin per IV
  • Drug: moxifloxacin per os
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass.
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Ghent Ghent Belgium

Sponsors and Collaborators

  • University Ghent

Investigators

  • Principal Investigator: Jan Van Bocxlaer, PhD, University Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01130922
Other Study ID Numbers:
  • 2010/099
First Posted:
May 26, 2010
Last Update Posted:
Apr 18, 2011
Last Verified:
Apr 1, 2011
Keywords provided by , ,
Roux-and-Y gastric bypass surgery
stable body weight
Additional relevant MeSH terms:
Body Weight
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination

Study Results

No Results Posted as of Apr 18, 2011