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

September 16, 2010 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: QAK423A Arm A
Drug: QAK423A
EXPERIMENTAL: QAK423A Arm B
Drug: QAK423A
EXPERIMENTAL: QAK423A Arm C
Drug: QAK423A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events associated with single doses of QAK423 in healthy subjects and mild to moderate COPD
Time Frame: 96 hours
96 hours
Adverse events associated with repeat doses in mild to moderate COPD patients
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of single and repeat doses of QAK423
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (ACTUAL)

February 1, 2005

Study Registration Dates

First Submitted

September 7, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (ESTIMATE)

September 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2010

Last Update Submitted That Met QC Criteria

September 16, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAK423A2101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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