Clinical trial NCT03479411 (phase 1, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: itraconazole powder, itraconazole 200 mg
SMILES: [Na+].[Cl-], CCC(C)N1N=CN(C1=O)C1=CC=C(C=C1)N1CCN(CC1)C1=CC=C(OC[C@H]2CO[C@@](CN3C=NC=N3)(O2)C2=CC=C(Cl)C=C2Cl)C=C1
Eligibility criteria:

        Inclusion Criteria:

        Part 1 (SAD) and Part 2 (MAD):

          1. Healthy males or non-pregnant, non-lactating healthy females.

          2. Age 18 to 60 years

          3. Screening forced expiratory volume in 1 sec (FEV1) ≥80% of the predicted value

          4. Screening FEV1/forced vital capacity (FVC) >0.70.

          5. Able to demonstrate the correct inhalation technique for use of delivery device during
             the study.

        Part 3 (Asthmatic Subjects):

          1. Males or non-pregnant, non-lactating females with a physician-confirmed diagnosis of
             asthma for at least 3 months. Asthma must be assessed by investigator as being stable
             for at least 4 weeks prior to screening.

          2. Age 18 to 60 years

          3. Subject is being treated with either inhaled corticosteroids (ICS) or inhaled
             corticosteroids plus long-acting beta-agonists (ICS/LABA). Only GINA STEP 2 and 3
             patients will be enrolled.

          4. Pre-bronchodilator, clinic measured, FEV1 ≥70% of predicted normal at screening

          5. Able to perform the required spirometric testing.

          6. Able to produce a sputum sample of a quality required for drug concentration
             assessments (a single repeat is permitted).

        Exclusion Criteria:

          1. Subjects who have received any IMP in a clinical research study within the previous 3
             months prior to dosing on this study

          2. Subjects who have previously received IMP in this study. Subjects who have
             participated in Part 1 are not permitted to participate in Part 2 or Part 3.

          3. History of any drug or alcohol abuse in the past 2 years prior to screening.

          4. Current users of e-cigarettes and nicotine replacement products and those who have
             used these products within the last 12 months

          5. Females of childbearing potential who are pregnant or lactating, or who plan to become
             pregnant during the study (all female subjects must have a negative pregnancy test at
             screening). A woman is considered of childbearing potential unless she is permanently
             sterile (hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral
             tubal occlusion/ligation) or is postmenopausal (had no menses for 12 months without an
             alternative medical cause (will be re-assessed at admission/pre-dose).

          6. Positive drugs of abuse test result at screening or admission

          7. Subjects with congestive heart failure or a history of congestive heart failure

          8. History of severe cough or bronchospasm upon inhalation of any dry powder inhalation
             product

          9. Subjects who are taking or have taken any herbal remedies or CYP3A4 inducers in the 28
             days prior to the first IMP administration

         10. Upper respiratory tract infection (excluding otitis media), fever, acute or chronic
             cough within 14 days of the first IMP administration, or lower respiratory tract
             infection within the last 3 months prior to IMP administration

         11. Recent (last 4 weeks prior to IMP administration) clinically significant bacterial,
             viral or fungal infection that required systemic (oral or intravenous) antibiotics,
             antivirals or antifungals; topical treatments, other than antifungals, are allowed.