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

Body Weight Clinical Trial

— DRUG10_MOXI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130922
• Other study ID #: 2010/099
• Status: Completed
• Phase: Phase 4
• First received: April 22, 2010
• Last updated: April 15, 2011
• Start date: March 2010
• Est. completion date: June 2010

Study information

• Verified date: April 2011
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Gastric Bypass

Intervention

Drug:
• moxifloxacin per IV
intravenous administration of 400 mg moxifloxacin (as a 1h-infusion)
• moxifloxacin per os
oral administration of 400 mg moxifloxacin in a single dose

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No