Bioavailability, Food Effect and Safety, Tolerability of a New Oral Suspension in Comparison to the Marketed Moxifloxacin Tablet in Healthy Adults

Condition(s) targeted: Healthy

Intervention: Moxifloxacin (Avelox, BAY12-8039) (Drug); Moxifloxacin (Avelox, BAY12-8039) (Drug); Moxifloxacin (Avelox, BAY12-8039) (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

Official title: Single-dose, Open-label, Randomized, Non-blinded, Three-fold Crossover Study in Healthy Subjects to Compare the Bioavailability of Moxifloxacin (BAY12-8039) 400 mg Tablet and 400 mg Oral Suspension Under Fasting Conditions, and to Investigate the Effect of Food on the Bioavailability of 400 mg Suspension.

Study design: Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Pharmacokinetics, as measured by maximum drug concentration in plasma and systemic drug exposure

Comparison of systemic drug exposures (tablet versus oral solution; oral solution with versus without food)

Secondary outcome: Safety/tolerability as assessed by clinical labs and adverse events.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Regular daily consumption of more than 1 L of xanthin-containing beverages

- Donation of more than 100 mL of blood within 4 weeks before the first study drug

administration or of approximately 500 mL in the preceding 3 months

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Wuppertal, Nordrhein-Westfalen 42096, Germany; Recruiting

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Starting date: May 2010
Last updated: September 24, 2010