A Safety and Efficacy Study of IPI-145 in mild Asthmatic Subjects

• Research type

  Research Study

• Full title

  A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose, Cross-Over, Efficacy and Safety Study of IPI-145 in Mild Asthmatic Subjects Undergoing Allergen Challenge

• IRAS ID

  106804

• Contact name

  Muna Albayaty

• Sponsor organisation

  Infinity Pharmaceuticals, Inc.

• Eudract number

  2012-001729-28

• ISRCTN Number

  1

• Research summary

  The new medicine tested in this study is a compound called IPI-145 which is being devoloped as a treatment for hematologic malignancies (types of cancer that affect blood, bone marrow, and lymph nodes) and inflammatory disease (a disease characterized by inflammation) indications. The main purpose of this study is to determine the effects of multiple doses of IPI-145 on lung function (how well the lungs work), inflammation (response of the lungs) and airway hyper responsiveness (increased sensitivity of the airways) in subjects with mild asthma after an allergen challenge. The study will determine how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. IPI-145 and placebo will be self-administered by subjects at home either as capsules or an oral solution which they will need to take up to twice a day for 14 days. Subjects will undergo the following procedures during the study: medical history and demographic data will be collected, physical examinations, lung function tests and allergen skin prick tests will be performed, height and weight will be measured, blood pressure, pulse rate and body temperature measurements will be taken, different kinds of urine, blood and sputum safety tests will be performed, blood samples for measurement of the concentration of study drug, any adverse events that participants experience and other medication they take, will be recorded. The study will be performed at the following sites: 1) PAREXEL Early Phase Clinical Unit, Northwick Park Hospital, Harrow, London. 2) PAREXEL Early Phase Clinical Unit, Klinikum Westend, Haus 17 Spandauer Damm 130, Berlin 3) Insal Respiratory Research, Biebricher Allee 34, 95187 Wiesbaden, Germany 4) Pulmonary Research Institute at Hospital Grosshansdorf, Center for Pneumology and Thoracic Surgery, Woehrendamm 80, D-22927 Grosshansdorf

• REC name

  Wales REC 2

• REC reference

  12/WA/0165

• Date of REC Opinion

  17 Jul 2012

• REC opinion

  Further Information Favourable Opinion