Study of Mometasone Furoate/Formoterol Fumarate Inhalation Combination in Healthy Volunteers

Condition(s) targeted: Healthy

Intervention: Mometasone furoate (Drug); Formoterol fumarate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Principal Investigator, Affiliation: Investigator site

This study will compare the performance of three combination metered dose inhalation devices and the variability of mometasone and formoterol doses delivered to the lungs in a healthy volunteer population

Official title: A Randomized, Single Dose, 3-Period Crossover Study to Evaluate the Dosage Form Proportionality, Dose Proportionality and Pharmacokinetics of Mometasone Furoate and Formoterol Fumarate From Three Combination MDI Formulations

Study design: Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study

Primary outcome: Dosage form and dose proportionality of mometasone and formoterol from combination metered dose inhalers (MDI).

Secondary outcome:

Extrapulmonary (systemic) effects and safety of mometasone and formoterol from combination MDI formulations.

Plasma and urine concentrations mometasone and formoterol

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy, male or female subjects age 18 to 65 years of age (included)

- In good health as confirmed by past medical history

- Female subjects must be either surgically sterilized at least 6 months prior to study

participation or post-menopausal (no regular menstrual bleeding for at least 2 years)

- Body mass index (BMI) within the range of 18. 5 to 32 kg/m2 and weigh at least 50 kg

- Able to communicate well with the investigator, to understand and comply with the

requirements of the study

- Understand and sign the written informed consent

Exclusion Criteria:

- Smokers (use of tobacco products in the previous 1 year with a pack year history of no

greater than 10 pack years).

- Female subjects who are pregnant, or lactating

- Treatment with any oral or intravenous corticosteroids within 1 month of the first

study treatment.

- Patients with a current respiratory tract infection or one within 1 month prior to

screening.

- Patients with a history of malignancy, myocardial infarction, untoward reactions to

sympathomimetic amines or inhaled medicine.

Subjects with a current or history of a clinically significant cardiac arrhythmia.

- Participation in any clinical investigation within 4 weeks prior to dosing or longer

if required by local regulation.

- Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.

- Significant illness within the two weeks prior to dosing.

- A past medical history of clinically significant ECG abnormalities.

- History of fainting, known hypersensitivity to the study drug or drugs similar to the

study drug. any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study, immunocompromise, including a positive HIV (ELISA and Western blot) test result, positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result, drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening evaluations.

Other protocol-defined inclusion/exclusion criteria may apply

Novartis, Horsham, United Kingdom

Starting date: November 2006
Last updated: June 21, 2007