NCT01073891

Brief Summary

The purpose of this study is to describe the pharmacokinetics of a new oral liquid moxifloxacin formulation and the influence of concommitant food intake on the pharmacokinetics in healthy adults compared to the marketed oral tablet. Pharmacokinetics is to see how the body absorbs, distributes and gets rid of the study drug. The absorption of the drug administered in a different dosage form may be altered due to the influence of different excipients used. The safety of moxifloxacin when administered as an oral liquid formulation will also be looked at. Results from this study will be used to guide dosing strategies of the larger clinical trial planned for children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started May 2010

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

July 1, 2015

Status Verified

June 1, 2015

Enrollment Period

6 months

First QC Date

February 22, 2010

Last Update Submit

June 30, 2015

Conditions

Healthy

Keywords

PharmacokineticsBioavailabilityFood effectOral liquid formulation

Outcome Measures

Primary Outcomes (4)

  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Moxifloxacin after a Single Dose

    AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC is defined as area under concentration versus time curve from time 0 (pre-dose) to extrapolated infinite time. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.

    0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose

  • Maximum Observed Drug Concentration (Cmax) of Moxifloxacin after a Single Dose

    Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.

    0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose

  • Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose(AUC/D) of Moxifloxacin after a Single Dose

    Geometric mean and percentage geometric coefficient of variation (%CV) were reported.

    0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose

  • Maximum Observed Drug Concentration Adjusted by Dose (Cmax/D) of Moxifloxacin after a Single Dose

    Geometric mean and percentage geometric coefficient of variation (%CV) were reported.

    0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose

Secondary Outcomes (7)

  • Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose per Kilogram Body Weight (AUC,norm) of Moxifloxacin after a Single Dose

    0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose

  • Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration [AUC(0-tlast)] of Moxifloxacin after a Single Dose

    0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose

  • Maximum Observed Plasma Concentration Divided by Dose per Kilogram Body Weight (Cmax,norm) of Moxifloxacin after a Single Dose

    0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose

  • Mean Residence Time (MRT) of Moxifloxacin after a Single Dose

    0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose

  • Time to Reach Maximum Drug Concentration in Plasma (tmax) of Moxifloxacin after a Single Dose

    0 hour (pre-dose), 15, 30, 45 minutes; 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours postdose

  • +2 more secondary outcomes

Study Arms (3)

Arm 1

ACTIVE COMPARATOR
Drug: Moxifloxacin (Avelox, BAY12-8039)

Arm 2

EXPERIMENTAL
Drug: Moxifloxacin (BAY12-8039)

Arm 3

EXPERIMENTAL
Drug: Moxifloxacin (BAY12-8039)

Interventions

Moxifloxacin (Avelox, BAY12-8039)DRUG

Single oral dose of moxifloxacin (Avelox, BAY12-8039) IR (immediate release) tablet 400 mg under fasting conditions

Arm 1
Moxifloxacin (BAY12-8039)DRUG

Single oral dose of moxifloxacin (BAY12-8039) oral suspension 400 mg under fasting conditions

Arm 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female subjects;
  • Age: 18 to 55 years (inclusive)
  • Body mass index (BMI): above/equal 18 and below/equal 30 kg/m²;
  • Women of childbearing age must have a negative pregnancy test and must use adequate contraception throughout the study and for 4 weeks afterwards

You may not qualify if:

  • Clinically relevant findings in the ECG
  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
  • Known hypersensitivity to moxifloxacin, other quinolones or to any of the excipients
  • Known severe allergies, non-allergic drug reactions, or multiple drug allergies
  • Relevant diseases within the last 4 weeks prior to the first study drug administration
  • Febrile illness within 1 week before the first study drug administration
  • Patients with a history of tendon disease/disorder related to quinolone treatment.
  • Congenital or documented acquired QT prolongation
  • Regular use of medicines (with the exception of contraceptives)
  • Pregnancy or lactation
  • Regular use of therapeutic or recreational drugs
  • Smoking more than 25 cigarettes daily
  • Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form
  • Suspicion of drug or alcohol abuse
  • Special diets preventing the subjects from eating the standard meals during the study
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Wuppertal, North Rhine-Westphalia, 42096, Germany

Location

Related Links

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 23, 2010

Study Start

May 1, 2010

Primary Completion

November 1, 2010

Study Completion

January 1, 2011

Last Updated

July 1, 2015

Record last verified: 2015-06

Locations

DE(1)