Safety, Tolerability and Pharmacokinetics of QAK423A in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197287
• Other study ID #: CQAK423A2101
• Status: Completed
• Phase: Phase 1
• First received: September 7, 2010
• Last updated: September 16, 2010
• Start date: May 2004

Study information

• Verified date: September 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. primary completion date: February 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• QAK423A

• QAK423A

• QAK423A

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events associated with single doses of QAK423 in healthy subjects and mild to moderate COPD		96 hours	Yes
Primary	Adverse events associated with repeat doses in mild to moderate COPD patients		14 days	Yes
Secondary	Pharmacokinetics of single and repeat doses of QAK423		14 days	No