Safety, Tolerability and Pharmacokinetics of QAK423A in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients
|ClinicalTrials.gov Identifier: NCT01197287|
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : September 17, 2010
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 or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: QAK423A||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||February 2005|
|Experimental: QAK423A Arm A||Drug: QAK423A|
|Experimental: QAK423A Arm B||Drug: QAK423A|
|Experimental: QAK423A Arm C||Drug: QAK423A|
- Adverse events associated with single doses of QAK423 in healthy subjects and mild to moderate COPD [ Time Frame: 96 hours ]
- Adverse events associated with repeat doses in mild to moderate COPD patients [ Time Frame: 14 days ]
- Pharmacokinetics of single and repeat doses of QAK423 [ Time Frame: 14 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197287
|Novartis Investigative Site|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|