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

NCT01197287 | Completed Phase 1

• 1 other identifier: CQAK423A2101
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (2)

• Adverse events associated with single doses of QAK423 in healthy subjects and mild to moderate COPD

  96 hours

• Adverse events associated with repeat doses in mild to moderate COPD patients

  14 days

Secondary Outcomes (1)

• Pharmacokinetics of single and repeat doses of QAK423

  14 days

Study Arms (3)

QAK423A Arm A

EXPERIMENTAL

Drug: QAK423A

QAK423A Arm B

EXPERIMENTAL

Drug: QAK423A

QAK423A Arm C

EXPERIMENTAL

Drug: QAK423A

Interventions

QAK423A DRUG

QAK423A Arm A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Berlin, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: September 9, 2010
• Study Start: May 1, 2004
• Primary Completion: February 1, 2005
• Last Updated: September 17, 2010

Record last verified: 2010-09

Locations

DE (1)