Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics of QAK423A in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01197287
Start Date
May 1 2004
Last Update
September 17 2010
Active Locations (1)
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1
Novartis Investigative Site
Berlin, Germany