A Phase 1 interventional study of Imatinib and Placebo oral capsule in Acute Lung Injury, sponsored by Exvastat Ltd.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-13.
Sponsored by Exvastat Ltd. · Phase 1, Interventional, and Treatment
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:
Female subjects must either be:
Exclusion Criteria:
Drug: Imatinib
Drug: Placebo oral capsule
Over-encapsulated 100 mg imatinib mesilate tablets
Matching placebo oral capsule
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
Time frame: 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
Time frame: 6 hours after the LPS challenge
Plan to share: No
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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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