Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

TERMINATED

Safety, Tolerability and Pharmacokinetics of ASM-024 Administered to Healthy Subjects and Subjects With Moderate Asthma

Lead Sponsor:

Asmacure Ltée

Conditions:

Asthma

Eligibility:

All Genders

18-55 years

Phase:

PHASE1

PHASE2

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of the dry powder formulation of ASM-024 following single and multiple administration by inhalation of ascending doses in healthy s...

Detailed Description

This is a phase I/II, randomized, double-blind, placebo-controlled study of single ascending and multiple ascending doses of ASM-024 administered by dry powder inhalation to healthy subjects and subje...

Eligibility Criteria

Inclusion

  • Healthy Volunteers:
  • Healthy male or female adult, 18 to 55 years of age ; non-smoker or former smoker;
  • Normal lung function; and
  • Normal 12-lead ECG
  • Asthmatics:
  • Male or female adult, 18 to 60 years of age with diagnosis of moderate asthma according to the GINA Guidelines and on regular inhaled corticosteroids with or without short or long-acting beta 2-agonists;
  • Non-smoker or former smoker;
  • FEV1 ≥ 70 % predicted in the absence of medications for asthma;
  • Baseline methacholine PC20 ≤ 16 mg/mL; and
  • Normal 12-lead ECG.

Exclusion

  • Healthy Volunteers:
  • Clinically significant illness or surgery within 8 weeks prior to first administration of the study medication;
  • Significant medical history that, in the Investigator's opinion, may adversely affect participation;
  • History of allergy or significant adverse reaction to drugs similar to ASM-024, to nicotine, or to cholinergic drugs or any drugs with a similar chemical structure;
  • History of hypersensitivity (anaphylaxis, angioedema) to any drug;
  • Use of any drug known to induce or inhibit hepatic drug metabolism, within 30 days prior to first administration of the study medication;
  • Positive pregnancy test for female subjects;
  • Use of medications known to prolong QT/QTc interval within 14 days prior to the first administration of the study medication;
  • Clinically significant 12 lead ECG abnormalities at Screening;;
  • Clinically significant physical examination or laboratory findings at Screening;
  • History of alcohol or drug abuse;
  • Tobacco use within 12 months prior to Screening, or nicotine-containing products within 6 months prior to Screening. History of smoking must be ≤ 10 pack-years;
  • Positive hepatitis B or C or HIV test at Screening;
  • Investigational drug within 30 days prior to first administration of the study medication, or long-acting investigational drug within 90 days prior to first administration of the study medication;
  • Previous exposure to ASM-024; and
  • Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control.
  • Asthmatics:
  • Clinically significant illness or surgery within 8 weeks prior to first administration of the study medication;
  • Significant medical history that, in the Investigator's opinion, may adversely affect participation;
  • History of allergy or significant adverse reaction to drugs similar to ASM-024, to nicotine, or to cholinergic drugs or any drugs with a similar chemical structure;
  • History of hypersensitivity (anaphylaxis, angioedema) to any drug;
  • Use of any drug known to induce or inhibit hepatic drug metabolism, within 30 days prior to first administration of the study medication;
  • Positive pregnancy test for female subjects;
  • Use of medications known to prolong QT/QTc interval;
  • Clinically significant 12 lead ECG at Screening;
  • Clinically significant physical examination or laboratory findings or abnormal vital signs;
  • Baseline methacholine PC20 \> 16 mg/mL at Screening;
  • History of illicit drug use or alcohol abuse within 12 months of Screening;
  • Tobacco use within 12 months prior to Screening, or nicotine-containing products within 6 months prior to Screening. History of smoking must be ≤ 10 pack-years;
  • Positive hepatitis B or C or HIV test at Screening;
  • Any of the following concomitant medications preceding the administration of methacholine during Screening and preceding the administration of the study medication at Visit 1: (i) oral or i.v. corticosteroids within 1 month; (ii) inhaled or intranasal corticosteroids within 48 hours; (iii) long-acting beta-2-agonists within 48 hours; (iv) short-acting beta-2-agonists within 8 hours; (v) anticholinergic aerosol within 24 hours; (vi) theophyline-containing products within 48 hours; (vii) NSAIDs within 7 days preceding the administration of methacholine during Screening and throughout the study; and (viii) antihistaminic drugs within 3 days;
  • Investigational drug within 30 days of Screening; long-acting investigational drug within 90 days of Screening;
  • Previous exposure to ASM-024; and
  • Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control.

Key Trial Info

Start Date :

March 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2014

Estimated Enrollment :

55 Patients enrolled

Trial Details

Trial ID

NCT01793298

Start Date

March 1 2013

End Date

December 1 2014

Last Update

February 10 2015

Active Locations (2)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (2 locations)

1

PharmaNet

Québec, Quebec, Canada, G1P 0A2

2

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada, G1V 4G5