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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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The purpose of this study is to assess the safety and tolerability of multiple oral doses of CTX-4430 when administered to cystic fibrosis (CF) patients once-daily (QD) for 15 days.This study will include two dose levels. For each dose level, blood samples will be collected for exploratory PK and PD assay validation. In addition, sputum will be collected for exploratory biomarker analysis. Following multiple dose administration, pulmonary function and exploratory lung clearance index (LCI) measurements will be taken.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Once daily oral capsule containing 50 or 100 mg of CTX-4430 |
|
| Placebo | Placebo Comparator | Once daily oral capsule containing mannitol, visibly identical to CTX-4430 capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTX-4430 | Drug | Ascending repeat doses of CTX-4430 will be administered orally, once-daily, to patients in 2 cohorts on days 1-15. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the safety and tolerability of multiple oral doses of CTX-4430 when administered to cystic fibrosis (CF) patients once-daily (QD) | Changes in clinical signs and symptoms of safety data that include physical examinations, ECGs, vital signs, pulse oximetry, pulmonary function (spirometry), clinical laboratory results, and adverse events which will be summarized descriptively and reported in tabular form. | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J Stuart Elborn, MD, FRCP | Queen's University, Belfast | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Medicinces Evaluation Unit | Wythenshawe | Manchester | M23 9QZ | United Kingdom | ||
| Celerion |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000625351 | acebilustat |
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Placebo | Drug | Repeat doses of placebo will be administered orally, once-daily, to patients in 2 cohorts on days 1-15 |
|
|
| Belfast |
| Northern Ireland |
| BT9 6AD |
| United Kingdom |
| Glasgow Clinical Research Facility | Glasgow | G31 2ER | United Kingdom |
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |