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AGO178C

Phase 1

Renal Impairment | Small molecule | Nephrology |Novartis AG|Last Updated: Dec 8, 2020

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01459250Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy SubjectsPHASE1 COMPLETED 32 — — Mar 1, 2011 -Dec 8, 20204 United States
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Study Endpoints
Primary Endpoints
Measure: Composite of AGO178C pharmacokinetics in blood and urine samples.
pre dose, 2 min, 5 min, 10 min, 20 min, 30 min, 45 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h and 36 h post dose
Secondary Endpoints
Measure: Safety and tolerability of AGO178C as assessed by adverse events reports, vital signs, ECGs and safety laboratory tests.
Up to 9 Days post dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
AGO178CEXPERIMENTAL -
Interventions
NameTypeDescription
AGO178CDRUG -
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Eligibility Criteria
Age Range18 Years — 79 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Mild, moderate, severe renally impaired or ESRD patients. * Healthy male or female subjects to match renally impaired patients in BMI (±15%), age (± 7 years) and gender (in this order). Smoking status (yes or no) will also be used as a final criterion, if deemed feasible by th...

Countries:United States
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