Text Size

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

This study is currently recruiting participants.
Verified April 2013 by Infinity Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01653756
First received: July 19, 2012
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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: 30
Study Start Date: July 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (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 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 cholinesterase inhibiting medication
  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 Recruiting
Harrow, United Kingdom
Contact: Albayaty, M.D.     0800 3898930        
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: April 16, 2013
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 May 16, 2013