Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005452-42 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: single dose escalation | Experimental |
| |
| Part B: 14 day repeat dose escalation (healthy volunteers) | Experimental |
| |
| Part C: 14 day repeat dose (asthma patients) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV1729 single dose | Drug | Safety and tolerability of single escalating doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events | Assessment of the number of adverse events reported by subjects following dosing. | 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. | 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. | 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 | 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 | Cohort 1, 49 days: Cohorts 2 & 3, 21 days; Cohorts 4, 5, 6 & 7, 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma RV1729 levels | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum biomarkers (measuring markers of inflammation in the blood) | Cohorts 4, 5, 6 & 7: Days 1 & 14 (0, 4 & 24 h), Day 4 (0 h) and Day 28 | |
| Exhaled Nitric Oxide (measuring airway inflammation) | Cohorts 4, 5, 6 & 7: Screening then Days 1 & 4 (0 h), Day 14 (0, 1 & 24 h) |
Inclusion Criteria:
Parts A & B (healthy volunteers only)
Part C (asthma patients only)
Exclusion Criteria:
Part C (asthma patients only)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jerome Boscia, MD | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London | NW10 7EW | United Kingdom | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
| RV1729 matching placebo single dose | Drug | Safety and tolerability of single escalating doses |
|
| RV1729: 14 day repeat dose | Drug | Safety and tolerability of repeat escalating doses |
|
| RV1729 matching placebo: 14 day repeat dose | Drug | Safety and tolerability of repeat escalating doses |
|
| Exhaled breath condensate (measuring markers of oxidative stress) | Cohorts 4, 5, 6 & 7: Screening then Days 1 & 14 (0 & 6 h) |
| Urinary cortisol, 4-beta hydroxycholesterol and Leukotriene E4 (LTE4) | Cohorts 4, 5, 6 & 7: Days -1 & 14 (0 to 24 h collection) |
| Sputum cells and biomarkers (measuring markers of inflammation in found in sputum) | Cohorts 6 & 7: Screening then Day 14 (6 h) |
| Manchester |
| M23 9QZ |
| United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000593769 | 6-(2-((4-amino-3-(3-hydroxyphenyl)-1H-pyrazolo(3,4-d)pyrimidin-1-yl)methyl)-3-(2-chlorobenzyl)-4-oxo-3,4-dihydroquinazolin-5-yl)-N,N-bis(2-methoxyethyl)hex-5-ynamide |
Not provided
Not provided
Not provided