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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002203-10 | EudraCT Number |
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The study is a randomized, double-blind, placebo-controlled clinical study of imatinib (as mesilate) in healthy subjects exposed inhaled lipopolysaccharide. During the study, eight oral doses of imatinib, or placebo, will each be taken 12 hours apart, before subjects are exposed to nebulized lipopolysaccharide (LPS). Four hours after LPS exposure, a bronchoalveolar lavage (BAL) will be undertaken, and BAL fluid (BALF collected. Once study assessments are completed, a follow-up visit will be conducted approximately 7 days after the last dose of imatinib.
The primary objective of the study is to investigate the effect of imatinib on LPS-induced pulmonary vascular dysfunction. The primary endpoints of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib | Drug | Over-encapsulated 100 mg imatinib mesilate tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of neutrophils in bronchoalveolar lavage fluid in subjects exposed to imatinib compared with placebo | Change in the number of neutrophils in bronchoalveolar lavage fluid in subjects exposed to imatinib compared with placebo | 6 hours after lipopolysaccharide inhalation |
| Change in concentration of total protein in bronchoalveolar lavage fluid in subjects exposed to imatinib compared with placebo | Change in concentration of total protein in bronchoalveolar lavage fluid in subjects exposed to imatinib compared with placebo | 6 hours after the LPS challenge |
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Inclusion Criteria:
Are able and willing to provide written informed consent to participate in this clinical study.
Healthy males and females, between 18 and 55 years old (both inclusive) at the screening visit.
Male subjects must practice an acceptable contraceptive method from the time of first IMP administration until 6 weeks after the follow-up visit.
Female subjects must either be:
Good general health as ascertained by detailed medical history and physical examination at the screening visit.
Body mass index ≥18.0 and ≤30 kg/m2 at the screening visit.
No clinically relevant abnormalities in the 12-lead ECG as per the Investigator's judgement at the screening visit
No clinically relevant abnormalities in results of clinical laboratory tests as per the Investigator's judgement at the screening visit.
Normal spirometry (FEV1 ≥ 85% of predicted, FEV1/FVC ratio ≥ 70%) at the screening visit.
Non-smokers or no history of smoking (including e-cigarettes and other forms of vaporizing/inhalation) in the last 6 months prior to the screening visit.
Subjects must be able to communicate well with the Investigator/designee.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muna Albayaty, MBBCh | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL Early Phase Clinical Unit | London | United Kingdom |
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| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| Placebo oral capsule |
| Drug |
Matching placebo oral capsule |
|
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |