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

NCT ID: NCT01197287

Last Updated: 2010-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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QAK423A Arm A

Group Type EXPERIMENTAL

QAK423A

Intervention Type DRUG

QAK423A Arm B

Group Type EXPERIMENTAL

QAK423A

Intervention Type DRUG

QAK423A Arm C

Group Type EXPERIMENTAL

QAK423A

Intervention Type DRUG

Interventions

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QAK423A

Intervention Type DRUG

QAK423A

Intervention Type DRUG

QAK423A

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CQAK423A2101

Identifier Type: -

Identifier Source: org_study_id