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QAK423A

Phase 1

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |Novartis AG|Last Updated: Sep 17, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment76

FDA Designations

No designations recorded

Clinical trial landscape

QAK423A · 1 trial · 1 indication

Phase 1 1
NCT01197287Safety, Tolerability and Pharmacokinetics of QAK423A in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) PatientsChronic Obstructive Pulmonary Disease
COMPLETED76 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetics of QAK423A in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Pharmacokinetics of single and repeat doses of QAK423
14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
QAK423A Arm AEXPERIMENTAL -
QAK423A Arm BEXPERIMENTAL -
QAK423A Arm CEXPERIMENTAL -

Interventions

NameTypeDescription
QAK423ADRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Germany
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Frequently asked questions about QAK423A

What is QAK423A used for?

QAK423A is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes QAK423A?

QAK423A is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS.

What phase is QAK423A in?

QAK423A is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for any use. The Phase 1 trial has been completed.

What clinical trials is QAK423A in?

QAK423A has one completed Phase 1 clinical trial, identified as NCT01197287. This trial evaluated the safety, tolerability, and pharmacokinetics of QAK423A in healthy volunteers and patients with Chronic Obstructive Pulmonary Disease (COPD).

Is QAK423A FDA approved?

QAK423A is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, and its safety and efficacy have not been established for any indication.