Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT01653756
Eligibility Criteria:
Inclusion Criteria:
* Male or female adults between 18 and 60 years of age
* Diagnosis of asthma (mild) for at least 6 months prior to Screening
* Forced expiratory volume in one second (FEV1) ≥70% of predicted value at Screening
* A positive skin prick test to test allergen
Exclusion Criteria:
* Any prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor other than IPI-145 in a previous clinical study
* Acute asthma exacerbations within 6 weeks prior to Screening
* Use of any medication for the treatment of asthma other than a short-acting β2 agonist (as needed) within the 4 weeks prior to Screening
* Participation in another clinical study within minimum of 30 days prior to study Screening
* A positive screen result for active or latent tuberculosis
* A history of cardiovascular disease
* The concomitant use of acid-reducing agents and cholinesterase inhibiting medication
* Inadequate hepatic function defined by Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) greater than 1.5 times greater limit of normal (ULN)
* Inadequate renal function defined by serum creatinine greater than 2.0 milligrams/dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01653756
Study Brief:
Protocol Section:
NCT01653756