A Phase 2a, Efficacy and Safety Study of IPI-145 in Mild Asthmatic Subjects

This study is currently recruiting participants.
Verified March 2014 by Infinity Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01653756
First received: July 19, 2012
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: IPI-145, a PI3K Inhibitor
Drug: Placebo to match IPI-145
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Infinity Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Forced Expiratory Volume in one second (FEV1) [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum concentration (Cmax), Area Under the Curve, and terminal elimination half-life (T1/2) pre-dose and up to 12 hours post dose [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: From signing of informed consent through 21 days following study drug administration ] [ Designated as safety issue: Yes ]
  • Change in C-reactive Protein (CRP) levels [ Time Frame: Screening and/or Day 1 of each treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPI-145/Placebo
Capsules
Drug: IPI-145, a PI3K Inhibitor
Active drug
Drug: Placebo to match IPI-145

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653756

Contacts
Contact: Laura Alexander, Msc. (617) 453-1426 Laura.Alexander@infi.com

Locations
Germany
Investigational Site Recruiting
Berlin, Germany
Investigational Site Recruiting
Grosshansdorf, Germany
Investigational Site Recruiting
Wiesbaden, Germany
United Kingdom
Investigational Site Active, not recruiting
Harrow, United Kingdom
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01653756     History of Changes
Other Study ID Numbers: IPI-145-03, 2012-001729-28
Study First Received: July 19, 2012
Last Updated: March 21, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Infinity Pharmaceuticals, Inc.:
Asthma
Allergen Challenge

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014