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AGO178

Phase 1

Hepatic Impairment | Small molecule | Gastrointestinal |Novartis AG|Last Updated: May 11, 2021

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

AGO178 · 1 trial · 1 indication

Phase 1 1
NCT01531309Pharmacokinetics of AGO178 in Participants With Liver ImpairmentHepatic Impairment
COMPLETED32 Analytics
PHASE1COMPLETED
Pharmacokinetics of AGO178 in Participants With Liver Impairment
Hepatic Impairment
NCT0153130932
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Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of AGO178
Predose, 2 minute (min) , 5 min , 10 min, 20 min, 30 min, 45 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 12h, 24h, 36h Post dose

Blood samples will be collected at various time points on day 1 and day 2

Area Under the Plasma Curve (AUC) of AGO178
Predose, 2 min , 5 min , 10 min, 20 min, 30 min, 45 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h, 36h Post dose

Blood samples will be collected at various time points on day 1 and day 2

Secondary Endpoints

Number of Participants with Adverse Events
Baseline and Day 8
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Mild Hepatic Impaired ParticipantsEXPERIMENTALMild hepatic impaired participants will receive a single sublingual dose of AGO178, 1 milligram (mg) on Day 1.
Moderate Hepatic Impaired ParticipantsEXPERIMENTALModerate hepatic impaired participants will receive a single sublingual dose of AGO178, 1 mg on Day 1.
Healthy Participants Matched by Aged, Gender and Body Mass Index (BMI)EXPERIMENTALHealthy participants matched by aged, gender and BMI will receive a single sublingual dose of AGO178, 1 mg on Day 1.

Interventions

NameTypeDescription
AGO178DRUGAGO178 is administered as a sublingual tablet.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants with liver disease confirmed within 3 months of screening. * If liver impairment is caused by alcohol use, participants must have abstained from alcohol use within 3 months of study start. * Participants must satisfy criteria for Child- Pugh Class A or B. Exclusi...

Countries:United States
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Frequently asked questions about AGO178

What is AGO178 used for?

AGO178 is an investigational small molecule being studied for use in hepatic impairment, which is reduced liver function. It is in Phase 1 clinical development, and the completed trial evaluated its pharmacokinetics in participants with liver impairment. The drug is not approved and remains under investigation.

Who makes AGO178?

AGO178 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company conducted a Phase 1 clinical trial to study the drug's pharmacokinetics in participants with liver impairment.

What phase is AGO178 in?

AGO178 is in Phase 1 clinical development. The single clinical trial for this drug, which studied its pharmacokinetics in participants with liver impairment, has been completed. AGO178 is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is AGO178 in?

AGO178 has one completed clinical trial, identified as NCT01531309, titled "Pharmacokinetics of AGO178 in Participants With Liver Impairment." This Phase 1 study enrolled 32 participants in the United States, including healthy volunteers, and evaluated the drug's pharmacokinetics in individuals with hepatic impairment.

Is AGO178 FDA approved?

AGO178 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only clinical trial for AGO178, which studied its pharmacokinetics in participants with liver impairment, has been completed, but the drug has not received marketing approval.