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AGO178C

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

AGO178C · 1 trial · 1 indication

Phase 1 1
NCT01459250Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy SubjectsRenal Impairment
COMPLETED32 Analytics
PHASE1COMPLETED
Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy Subjects
Renal Impairment
NCT0145925032
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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 to 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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Frequently asked questions about AGO178C

What is AGO178C used for?

AGO178C is an investigational small molecule being studied for use in renal impairment. It is being evaluated in patients with renal deficiencies to understand how the drug behaves in this population compared with healthy subjects.

Who makes AGO178C?

AGO178C is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. The company is conducting clinical research to evaluate the drug's pharmacokinetics, safety, and tolerability in subjects with renal impairment.

What phase is AGO178C in?

AGO178C is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety, tolerability, and how the body processes it in patients with renal impairment.

What clinical trials is AGO178C in?

AGO178C has one completed Phase 1 clinical trial, identified as NCT01459250. This study evaluated the pharmacokinetics, safety, and tolerability of AGO178C in subjects with renal deficiencies compared with healthy subjects. The trial enrolled 32 participants in the United States.

Is AGO178C the same as any other drug?

No alternative names for AGO178C have been disclosed. The drug is identified solely by its code name AGO178C in clinical trial records and by its developer, Novartis AG.