SMP-028/ketoconazole drug: drug interaction study

INTERVENTION: Subjects will be randomised (in a 1:1 ratio) into one of two treatment sequences (Treatment A followed by Treatment B or Treatment B followed by Treatment A): Treatment A consists of Ketoconazole 400 mg daily, administered orally twice a day on Days 1 to 7 followed by a single oral dose of SMP‐028 20 mg on the morning of Day 5. Treatment B consists of a single dose of SMP‐028 20 mg on Day 1. Subjects will be followed up for 8 days after dosing in Treatment A and 4 days in Treatment B. CONDITION: Asthma ; Respiratory ; Asthma PRIMARY OUTCOME: Pharmacokinetics: ; 1. Primary endpoints:; Comparative SMP‐028 exposure between treatment periods (AUC[0‐8] and C[max]) over 72 hours ; 2. Secondary endpoints:; Comparative SMP‐028 exposure between treatment periods (other pharmacokinetic parameters), and exposure levels of the metabolites of SMP‐028 over 72 hours SECONDARY OUTCOME: Safety endpoints: ; 1. The proportion of subjects with adverse events (AEs) ; 2. Changes in standard laboratory safety tests ; 2.1. haematology ; 2.2. clinical chemistry ; 2.3. urinalysis ; 3. Concomitant medication review ; 4. Vital signs ; 5. Complete physical examinations ; 6. 12‐lead ECG INCLUSION CRITERIA: Healthy subjects aged 18 to 55 years who are in good health as determined by past medical history, physical examination, electrocardiogram, clinical safety laboratory tests and urinalysis