Back to resultsSafety, Tolerability and Pharmacokinetics of QAK423A in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
QAK423A
QAK423A
QAK423A
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease
Eligibility Criteria
Inclusion Criteria:
Part A:
- Healthy, male subjects aged 18-55 years of age able to provide written informed consent prior to study participation and determined as in good health by past medical history, physical examination, ECG, laboratory tests and urinalysis.
Parts B and C:
- Male or female (post menopausal or surgically sterilized) patients with COPD, aged 40-75 years, with a smoking history of at least 10 pack years (i.e. smokers or ex-smokers).
- Diagnosis of mild or moderate COPD, according to the GOLD guidelines.
- Post-bronchodilator FEV1 at screening 50-80% of predicted.
- No COPD exacerbations within the 3 months prior to dosing, no concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery.
- No medical conditions that may jeopardize the subjects participation in the study
- Weigh less than 100 kg
Exclusion Criteria:
- Use of any prescription drug or over-the-counter (OTC) medication within 2 weeks prior to dosing.
- History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- History of clinically significant drug allergy. A known hypersensitivity to the study drug or drugs similar to the study drug.
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
QAK423A Arm A
QAK423A Arm B
QAK423A Arm C
Arm Description
Outcomes
Primary Outcome Measures
Adverse events associated with single doses of QAK423 in healthy subjects and mild to moderate COPD
Adverse events associated with repeat doses in mild to moderate COPD patients
Secondary Outcome Measures
Pharmacokinetics of single and repeat doses of QAK423
Full Information
NCT ID
NCT01197287
First Posted
September 7, 2010
Last Updated
September 16, 2010
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01197287
Brief Title
Safety, Tolerability and Pharmacokinetics of QAK423A in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
A Randomized, Double-blind, Placebo-controlled Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of QAK423 in Healthy Subjects and COPD Patients and Multiple, Titrated Dosing in COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
There are three elements to this study:
Part A: Single dose escalation in healthy subjects. 6 dose levels of QAK423 are planned in healthy volunteers.
Part B: Single dose escalation in patients with mild/moderate COPD. 3 dose levels of QAK423 are planned in COPD patients.
Part C: Titrated repeat dosing for a maximum of 14 days in mild/moderate COPD patients.
Repeat dosing is planned in COPD patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic obstructive pulmonary disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QAK423A Arm A
Arm Type
Experimental
Arm Title
QAK423A Arm B
Arm Type
Experimental
Arm Title
QAK423A Arm C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
QAK423A
Intervention Type
Drug
Intervention Name(s)
QAK423A
Intervention Type
Drug
Intervention Name(s)
QAK423A
Primary Outcome Measure Information:
Title
Adverse events associated with single doses of QAK423 in healthy subjects and mild to moderate COPD
Time Frame
96 hours
Title
Adverse events associated with repeat doses in mild to moderate COPD patients
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics of single and repeat doses of QAK423
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Part A:
Healthy, male subjects aged 18-55 years of age able to provide written informed consent prior to study participation and determined as in good health by past medical history, physical examination, ECG, laboratory tests and urinalysis.
Parts B and C:
Male or female (post menopausal or surgically sterilized) patients with COPD, aged 40-75 years, with a smoking history of at least 10 pack years (i.e. smokers or ex-smokers).
Diagnosis of mild or moderate COPD, according to the GOLD guidelines.
Post-bronchodilator FEV1 at screening 50-80% of predicted.
No COPD exacerbations within the 3 months prior to dosing, no concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery.
No medical conditions that may jeopardize the subjects participation in the study
Weigh less than 100 kg
Exclusion Criteria:
Use of any prescription drug or over-the-counter (OTC) medication within 2 weeks prior to dosing.
History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
History of clinically significant drug allergy. A known hypersensitivity to the study drug or drugs similar to the study drug.
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability and Pharmacokinetics of QAK423A in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients
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