Safety, Tolerability and Pharmacokinetics of QAK423A in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients
This study has been completed.
Information provided by:
First received: September 7, 2010
Last updated: September 16, 2010
Last verified: September 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.
|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 ]
|Study Start Date:||May 2004|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
|Experimental: QAK423A Arm A||Drug: QAK423A|
|Experimental: QAK423A Arm B||Drug: QAK423A|
|Experimental: QAK423A Arm C||Drug: QAK423A|
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