Efficacy and Safety of Navarixin (SCH 527123) in Participants With Allergen-Induced Asthma (P05363)
Efficacy and Safety of Navarixin (SCH 527123) in Participants With Allergen-Induced Asthma (P05363)
Evaluation of treatment in participants with mild asthma.
To evaluate the effect of navarixin (MK-527123, SCH 527123) treatment on allergen-induced
 late asthmatic response (LAR) in participants with mild asthma.
Inclusion Criteria:

 -  Man or woman 18 to 65 years of age of any race.

 -  Has mild, stable, allergic asthma as defined by American Thoracic Society criteria.

 -  Has history of episodic wheezing and shortness of breath.

 -  Has Forced Expiratory Volume in 1 second (FEV1) of at least 70% of predicted at
 Screening and within 10% of preallergen screening value at both baselines.

 -  Has positive methacholine challenge at Screening. Methacholine challenges are
 considered positive if decreases of at least 20% in the FEV1 occur at a concentration
 of less than or equal to 16 mg/mL.

 -  Baseline methacholine PC20 (concentration that initiated a 20% fall in FEV1) must be
 within 1 doubling concentration of the preallergen screening PC20 to enter treatment.

 -  Has positive skin-prick test to common allergens (cat, dust mite, grass, pollen).

 -  Has a positive Early Asthmatic Response of >=20% fall in FEV1 measured from the FEV1
 immediately prior to challenge, and Late Asthmatic Response of >=15% fall in FEV1 from
 the FEV1 measured immediately prior to challenge during Screening period.

 -  Has been free from asthma exacerbation for at least 4 weeks before Screening. An
 exacerbation is defined as an occurrence of any clinical deterioration of asthma that
 requires emergency treatment, hospitalization due to asthma, or treatment with
 additional medication, as judged by the clinical investigator.

 -  Has been free from relevant seasonal allergen exposure for at least 4 weeks before the
 study and be able to remain so for the duration of the study.

 -  Has a current nonsmoking status. If previous smokers, cumulative smoking history must
 be fewer than 10 pack-years (pack-year=20 cigarettes smoked daily for 1 year).
 Previous smokers must not have smoked within 1 year before Screening.

 -  Is willing to give written informed consent to participate in the study.

 -  Has the ability to comply with the dosing regimen, to adhere to the visit schedule,
 and to participate in all treatment procedures, including sputum induction.

 -  Female participant of childbearing potential must have a negative serum pregnancy
 tests (human chorionic gonadotropin; hCG) at Screening and must use a medically
 acceptable, highly effective, adequate form of birth control (ie, failure rate <1% per
 year when used consistently and correctly) prior to Screening and agrees to continue
 using it while in the study (Screening and Treatment Periods). Medically acceptable,
 highly effective forms of birth control include hormonal implants, oral
 contraceptives, hormonal patches, intravaginal ring, medically acceptable prescribed
 intrauterine devices (IUDs), and a monogamous relationship with a male partner who has
 had a vasectomy. A female participant who is not of childbearing potential must have a
 medical record of being surgically sterile (eg, hysterectomy, tubal ligation), or be
 at least 1 year postmenopausal. Absence of menses for at least 1 year will indicate
 that a female is postmenopausal. A female participant should be encouraged to continue
 using a highly effective method of birth control for 30 days following the end of
 treatment.

 -  Participants, if male and sexually active with women of childbearing potential, must
 agree to use an adequate form of contraception for the duration of the study and to
 have sexual relations with only those women who use a highly effective birth control
 method.

 -  Clinical laboratory tests (complete blood count [CBC], blood chemistries, and
 urinalysis) must be within normal limits or clinically acceptable to the
 investigator/sponsor.

 Exclusion Criteria:

 -  Has had a diagnosis of chronic obstructive pulmonary disease (COPD) or any other
 clinically relevant lung disease (eg, cystic fibrosis, pulmonary fibrosis,
 bronchiectasis) other than mild allergic asthma, or has a history of having been
 intubated.

 -  Has had a worsening of a respiratory tract infection within 4 weeks before Screening.

 -  Has had any clinically significant abnormality; history of clinically significant
 hypotensive episodes of fainting, dizziness, or lightheadedness; history or symptoms
 of cardiovascular disease; significant neurologic disease; or hematologic abnormality,
 including coagulopathy; or has a medication regimen or clinically relevant medical
 condition other than asthma that may interfere with the effect of study medication.

 -  Had a peripheral blood neutrophil (PBN) count of <3 × 10^9/L at the Screening Visit.

 -  Has an allergy/sensitivity to the study drug or its excipients.

 -  Is pregnant, breast-feeding, or intends to become pregnant during the study.

 -  Has used any investigational drug within 30 days or 5 half-lives of Screening.

 -  Is presently participating in any other clinical study.

 -  Is part of the staff personnel directly involved with this study

 -  Is a family member of the investigational study staff.

 -  Has received any treatment prohibited by the protocol (Table 3), or any medication
 that may interfere with the effect of the study medication more recently than the
 indicated washout period prior to Screening, or must continue to receive the
 prohibited treatment.