PC945 is a new medicine being developed for treatment of fungal lung diseases. The main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single and repeat doses of PC945
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
29
Safety and tolerability of single doses
Safety and tolerability of single doses
Safety and tolerability of repeat doses
Parexel EPCU
Harrow, Middlesex, United Kingdom
Incidence of treatment emergent adverse events
Assessment of number of adverse events reported by subjects following dosing
Time frame: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks
12-lead ECG assessment
Change from pre-dose values
Time frame: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks
Vital signs assessment (blood pressure and heart rate - measured together)
Change for pre-dose values
Time frame: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks
Clinical laboratory assessments (blood and urine samples - measured together)
Change from pre-dose values
Time frame: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks
Spirometry assessment (FEV1 & FVC - measured together)
Change from pre-dose values
Time frame: Cohort 1 - 12 weeks; Cohort 2 - 7 weeks; Cohort 3 - 6 weeks
Plasma concentration data of PC945
Blood levels of PC945 measured after dosing
Time frame: Cohort 1 (4 treatment periods) & Cohort 3 (1 treatment period) Day1 = 8 samples; Day2 = 2 samples; Day3 = 1 sample; F/U = 1 sample. Cohort 2 - Days1&7 = 10 samples; Days2,5,6 = 1 sample; Day8 = 2 samples; Day9 = 1 sample; F/U = 1 sample
Spirometry assessment (FEV1)
Observed drops in FEV1 assessment after dosing patients with mild asthma
Time frame: Cohort 3 only - Day 1, 8 hours
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Safety and tolerability of repeat doses