| Eligibility |
Inclusion Criteria
- Healthy male or female subjects aged 18 to 50 years (inclusive).
- Females will be eligible only if they are currently non-lactating and demonstrate a
negative urine pregnancy test. Female subjects must be willing to use highly effective
methods of contraception throughout the study. A highly effective method of birth
control is defined as one which results in a low failure rate (i.e. less than 1% per
year) when used consistently and correctly e.g. no sexual intercourse, using
contraceptive foam AND a condom (double-barrier). [NOTE: for this study, use of
hormonal contraception is an exclusion]
- Body mass index (BMI) between 18.5 and 30.0 kg/m2.
- Non-smoker for at least 12 months prior to study screening and a maximum smoking
history of less than ten-pack years (i.e. the equivalent of one-pack per day for ten
years).
- Free of significant abnormal findings as determined by medical history, physical
examination, vital signs, and laboratory tests (including serum cortisol at
screening), complete blood count (CBC) with differential , urinalysis and basic
metabolic panel.
- Ability to read, comprehend and sign the informed consent form.
- Ability and willingness to comply with all study procedures, discontinue and/or
withhold medications as specified in the protocol, and attend scheduled study visits.
- No history of major respiratory disease (such as cystic fibrosis or COPD).
- Able to demonstrate correct nasal spray technique at screening.
Exclusion Criteria
- Any history and/or conditions that might interfere with drug absorption, distribution,
metabolism or excretion of MF, e.g., preexisting lung and liver disease.
- Known or suspected sensitivity or allergic reaction to MF, or related compounds in
that class, or one of the excipients, or to activated charcoal.
- Known or suspected sensitivity to benzalkonium chloride or to products containing this
salt.
- Having a history and/or currently having the medical condition in the opinion of
medically accountable investigator and hence taking any medication for the following
(including but not limited to):
- Significant cardiac, dermatologic, gastrointestinal, hepatic, renal,
hematological, neurological and psychiatric disease (determined by physical exam,
CBC with differential, urinalysis, basic metabolic panel and medical history).
- Presence of glaucoma, cataracts, ocular herpes simplex or carcinoma (other than
basal cell).
- Presence of tuberculosis and other respiratory diseases (including but not
limited to intermittent or persistent asthma, emphysema and chronic bronchitis);
or respiratory infection, common cold, sinusitis or ear infections.
- Based on the medical interview, physical examination or screening investigations,
subject is unfit for the study in the opinion of the medically accountable
investigator.
- Current use of hormone replacement therapy (HRT), hormonal contraceptives (oral,
implants, or IUDs) and/or use corticosteroid within the last 2 month.
- Atrophic rhinitis or rhinitis medicamentosa within the last 60 days.
- Any history of nasal surgery or known clinically relevant abnormalities, such as
rhinitis medicamentosa, polyposis, septum deviation with clinical symptoms, recent
nasal trauma, or nasal structural abnormalities.
- History of recurrent epistaxis, or any epistaxis requiring medical intervention.
- Known perennial airway allergies or vasomotor rhinitis.
- Known seasonal airway allergies within the last six weeks prior to the start of the
study or seasonal airway allergies that likely become acute during the study period.
Subjects may be included in the study, if e.g. a mild or unlikely seasonal airway
allergy does not interfere with the nasal absorption of mometasone furoate in the
opinion of the medically accountable investigator and principal investigator.
- Acute sinusitis within the last six weeks prior to enrollment.
- History of chronic sinus disease or sinusitis within the last year prior to the start
of study.
- Use of any systemic, topical, inhaled, or nasal corticosteroid within 30 days prior to
enrollment.
- Use of any prescription, over-the-counter, or complementary nasally administered
products within 30 days prior to enrollment and for the duration of the study (i.e.,
corticosteroids, decongestants, antihistamines, saline sprays, sinus washes).
- Use of any topically applied agents to the nasal mucosa (i.e., antibacterial creams,
Vaseline) within 30 days of enrollment.
- History of malignancy within the past five years.
- Any concurrent medication or any medication within 2 weeks preceding the start of the
study (infrequent intake/use of drugs may be accepted, if judged by the investigator
to have no clinical relevance and no influence on study outcome).
- Exposure to any investigational drug within 30 days of enrollment. Exposure to any
medication/food that alters the CYP 3A4 activity within last 2 weeks (e.g. any
grapefruit products, azole anti-fungals, or rifampin).
- Subjects who have donated 14.85 ounces (450 mL) blood or more within the previous 8
weeks prior to study administration.
- Any history of current drug or alcohol abuse, which would interfere with the subject's
completion of the study and with adherence to the protocol.
- Subject reports a regular xanthine consumption of > 5 cups of coffee or black tea per
day (or equivalent xanthine consumption per day using other products).
- Subject reports strict dietary habits, which would preclude the subject's acceptance
of standardized meals.
- A subject will not be eligible for this study if he/she is an immediate family member
of the participating investigator, co-investigators, study coordinator, or employee of
the participating investigator.
- The subject is a student of the Principal Investigator or co-investigators.
- Lack of willingness to have personal study related data collected, archived and
transmitted according to the protocol.
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