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FIA586

Phase 1

Hepatic Impairment | Small molecule | Gastrointestinal |Novartis AG|Last Updated: Jun 20, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED

Total Trials1

Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

FIA586 · 1 trial · 1 indication

Phase 1 1

NCT04993157Pharmacokinetics Study of FIA586 in Participants With Mild and Moderate Hepatic ImpairmentHepatic Impairment

COMPLETED54 Analytics

PHASE1COMPLETED

Pharmacokinetics Study of FIA586 in Participants With Mild and Moderate Hepatic Impairment

Hepatic Impairment

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Study Endpoints

Primary Endpoints

Maximum Observed Blood Concentrations (Cmax) for FIA586

pre-dose, 0.25 hours, 0.5 hours, 1 hour, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, 72 hours, 92 hours and 120 hours

Blood samples will be collected to measure Cmax at indicated time-points. Pharmacokinetic (PK) parameters will be calculated based on FIA586 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC MS/MS) method with a lower limit of quantification of 20 ng/mL. Cmax will be determined using non-compartmental methods.

Area Under Plasma Concentration-time Curve from time zero to the last measurable concentration sampling time (AUClast) for FIA586

pre-dose, 0.25 hours, 0.5 hours, 1 hour, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, 72 hours, 92 hours and 120 hours

Blood samples will be collected to measure AUClast at indicated time-points. Pharmacokinetic (PK) parameters will be calculated based on FIA586 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC MS/MS) method with a lower limit of quantification of 20 ng/mL. AUClast will be determined using non-compartmental methods.

Area Under Plasma Concentration-time Curve from Time Zero Extrapolated to Infinity (AUC[0-inf]) for FIA586

pre-dose, 0.25 hours, 0.5 hours, 1 hour, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, 72 hours, 92 hours and 120 hours

Blood samples will be collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic (PK) parameters will be calculated based on FIA586 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC MS/MS) method with a lower limit of quantification of 20 ng/mL. AUC\[0-inf\] will be determined using non-compartmental methods

Area Under Plasma Concentration-time Curve from time 0 to 48 hours (AUC0-48h) for FIA586

pre-dose, 0.25 hours, 0.5 hours, 1 hour, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours and 48 hours

Blood samples will be collected to measure AUC0-48h at indicated time-points. Pharmacokinetic (PK) parameters will be calculated based on FIA586 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC MS/MS) method with a lower limit of quantification of 20 ng/mL. AUC0-48h will be determined using non-compartmental methods.

Time to Reach Maximum Blood Concentrations (Tmax) for FIA586

pre-dose, 0.25 hours, 0.5 hours, 1 hour, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, 72 hours, 92 hours and 120 hours

Blood samples will be collected to measure Tmax at indicated time-points. Pharmacokinetic (PK) parameters will be calculated based on FIA586 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC MS/MS) method with a lower limit of quantification of 20 ng/mL. Tmax will be determined using non-compartmental methods.

Terminal Elimination Half-life (T1/2) for FIA586

pre-dose, 0.25 hours, 0.5 hours, 1 hour, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, 72 hours, 92 hours and 120 hours

Blood samples will be collected to measure T1/2 at indicated time-points. Pharmacokinetic (PK) parameters will be calculated based on FIA586 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC MS/MS) method with a lower limit of quantification of 20 ng/mL. T1/2 will be determined using non-compartmental methods.

Apparent Clearance (CL/F) of FIA586

pre-dose, 0.25 hours, 0.5 hours, 1 hour, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, 72 hours, 92 hours and 120 hours

Blood samples will be collected to estimate CL/F at indicated time-points. Pharmacokinetic (PK) parameters will be calculated based on FIA586 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC MS/MS) method with a lower limit of quantification of 20 ng/mL.

Apparent volume of distribution during terminal elimination phase (Vz/F) of FIA586

pre-dose, 0.25 hours, 0.5 hours, 1 hour, 1,5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours, 72 hours, 92 hours and 120 hours

Blood samples will be collected to estimate Vz/F at indicated time-points. Pharmacokinetic (PK) parameters will be calculated based on FIA586 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC MS/MS) method with a lower limit of quantification of 20 ng/mL.

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Study Design & Arms

AllocationNON_RANDOMIZED

MaskingNONE

ModelPARALLEL

PurposeTREATMENT

Treatment Arms

Arm	Type	Description
Group 1: Healthy participants with normal hepatic function	EXPERIMENTAL	Each participant will receive a single dose of FIA586
Group 2: Participants with mild hepatic impairment	EXPERIMENTAL	Each participant will receive a single dose of FIA586
Group 3: Participants with moderate hepatic impairment	EXPERIMENTAL	Each participant will receive a single dose of FIA586

Interventions

Name	Type	Description
FIA586	DRUG	FIA586 capsule

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Eligibility Criteria

Age Range18 Years to 70 Years

SexALL

Healthy VolunteersYes

Study Sites2

Inclusion Criteria: All Participants: * Male and non-childbearing potential female participants 18 to 70 years of age (inclusive) at Screening. * Must weigh at least 50.0 kg and must have a body mass index (BMI) within the range of 18.0 to - 38.0 kg/m2 at Screening. * Must be a non-smoker or agree...

Countries:United States

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Frequently asked questions about FIA586

What is FIA586 used for?

FIA586 is an investigational small molecule being studied for use in hepatic impairment. It is being developed by Novartis AG (NVS) and is currently in Phase 1 clinical development. The drug is intended for patients with mild and moderate hepatic impairment.

What does FIA586 target?

FIA586 is a small molecule being developed by Novartis AG (NVS). Its specific molecular target has not been disclosed in available clinical trial information. The drug is currently in Phase 1 development for hepatic impairment.

Who makes FIA586?

FIA586 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is an investigational small molecule currently in Phase 1 clinical development for hepatic impairment.

What phase is FIA586 in?

FIA586 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for use in patients with mild and moderate hepatic impairment.

What clinical trials is FIA586 in?

FIA586 has one completed clinical trial registered under NCT04993157, titled "Pharmacokinetics Study of FIA586 in Participants With Mild and Moderate Hepatic Impairment." This Phase 1 study enrolled 54 participants in the United States and included healthy volunteers.

Is FIA586 the same as any other drug?

FIA586 is an investigational small molecule developed by Novartis AG (NVS). No alternative names for FIA586 have been disclosed in available clinical trial records. The drug is currently in Phase 1 development for hepatic impairment.