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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01197287
First received: September 7, 2010
Last updated: September 16, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: QAK423A
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Adverse events associated with single doses of QAK423 in healthy subjects and mild to moderate COPD [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
  • Adverse events associated with repeat doses in mild to moderate COPD patients [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of single and repeat doses of QAK423 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: May 2004
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QAK423A Arm A Drug: QAK423A
Experimental: QAK423A Arm B Drug: QAK423A
Experimental: QAK423A Arm C Drug: QAK423A

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197287

Locations
Germany
Novartis Investigative Site
Berlin, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01197287     History of Changes
Other Study ID Numbers: CQAK423A2101
Study First Received: September 7, 2010
Last Updated: September 16, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 01, 2014