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QAK423A

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment76
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01197287Safety, Tolerability and Pharmacokinetics of QAK423A in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) PatientsPHASE1 COMPLETED 76 — — May 1, 2004 -Sep 17, 20101 Germany
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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 — 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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