RV1729 is a new medicine being developed for possible treatment of asthma and smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD). The main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single and repeat doses of RV1729.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
63
Safety and tolerability of single escalating doses
Safety and tolerability of single escalating doses
Safety and tolerability of repeat escalating doses
Unnamed facility
London, United Kingdom
Unnamed facility
Manchester, United Kingdom
Incidence of treatment emergent adverse events
Assessment of the number of adverse events reported by subjects following dosing.
Time frame: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days
ECG Assessment (12-lead ECG)
Change from pre-dose values.
Time frame: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days
Vital sign assessment (blood pressure & heart rate)
Change from pre-dose values.
Time frame: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days
Spirometry assessment (FEV1 & FVC)
Change from pre-dose values
Time frame: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days
Clinical laboratory assessments (blood and urine samples)
Change from pre-dose values
Time frame: Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days
Plasma RV1729 levels
Time frame: Cohort 1: Day 1 (0,10,15&30min,1,2,4,6&24h), 5 treatment periods. Cohorts 2&3: Day 1 (0,10,15&30min 1,2,4,6,8,12h), Days 2-8 (24,48,72,96,120,144&168h). Cohorts 4,5,6&7: Days 1, 7&14 (0,10,15&30min,1,2,4,6,8,10,12&24h) & Days 8-13 & 16-21 & 28 (0h)
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Safety and tolerability of repeat escalating doses