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

This study has been completed.
Sponsor:
Information provided by:
University Ghent
ClinicalTrials.gov Identifier:
NCT01130922
First received: April 22, 2010
Last updated: April 15, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Gastric Bypass
Body Weight
Drug: moxifloxacin per IV
Drug: moxifloxacin per os
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass.

Resource links provided by NLM:


Further study details as provided by University Ghent:

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 [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: March 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130922

Locations
Belgium
University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Ghent
Investigators
Principal Investigator: Jan Van Bocxlaer, PhD University Ghent
  More Information

No publications provided by University Ghent

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jan Van Bocxlaer, PhD, University Ghent
ClinicalTrials.gov Identifier: NCT01130922     History of Changes
Other Study ID Numbers: 2010/099
Study First Received: April 22, 2010
Last Updated: April 15, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

Keywords provided by University Ghent:
Roux-and-Y gastric bypass surgery
stable body weight

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014