Asthma
Conditions
Keywords
Asthma, Allergen Challenge
Brief summary
The purpose of this study is to examine the effects of multi-dose regimens of IPI-145 on lung function in mild asthmatic subjects following allergen challenge.
Detailed description
This is a phase 2a, randomized, double-blind, placebo-controlled, multi-dose, 2-way cross-over study designed to examine the effect of IPI-145 on lung function and inflammatory indices in mild, allergen-reactive asthmatic subjects undergoing allergen challenge.
Interventions
DRUGIPI-145, a PI3K Inhibitor
Active drug
DRUGPlacebo to match IPI-145
Comparator
Sponsors
SecuraBio
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced Expiratory Volume in one second (FEV1) | Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax), Area Under the Curve, and terminal elimination half-life (T1/2) pre-dose and up to 12 hours post dose | Day 14 |
| Number of Participants with Adverse Events as a Measure of Safety | From signing of informed consent through 21 days following study drug administration |
| Change in C-reactive Protein (CRP) levels | Screening and/or Day 1 of each treatment period |
Countries
Germany, United Kingdom
Outcome results
None listed