Hepatic ImpairmentPhase 1NCT04993157
Pharmacokinetics Study of FIA586 in Participants With Mild and Moderate Hepatic Impairment
A Phase 1 study testing FIA586 in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 2 sites in United States.
Trial summary
This is a Phase I study designed to characterize the pharmacokinetics (PK), safety, and tolerability of a single oral dose of FIA586 in participants with mild and moderate hepatic impairment (HI) compared to matched healthy participants.The information obtained in this study will help to determine whether dosage… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- FIA586
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Dec 2021to 28 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 to smoke no more than 5 cigarettes (or equivalent) per day, and maintain the same smoking status from Screening until the Study Completion (Day -28 to Day 6).
- Healthy participants (Group 1)
- Must be in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at Screening.
Show all 11Show fewer
- Each participant must match in age (±10 years), gender, weight (±15%), and smoking status (smoker or non-smoker) to an individual participant in at least one HI group but not to more than 1 participant in the same HI group.
- Participants with mild and moderate HI (Groups 2 and 3)
- Must satisfy the criteria for HI as evidenced by a Child-Pugh class of A or B at Screening:
- Class A; Mild; Child-Pugh score 5-6
- Class B; Moderate; Child-Pugh score 7-9
Who cannot join
- All participants:
- Use of other investigational drugs within the last 30 days or 5 half-lives prior to dosing of study treatment, whichever is longer.
- Known history of, or current clinically significant arrhythmias. Have clinically significant ECG abnormality or history of long-QT syndrome.
- Myocardial infarction < 5 years prior to Screening.
- Recent (within the last 3 years of Screening) or recurrent history of autonomic dysfunction (e.g. recurrent episodes of fainting or palpitations).
- History of immunodeficiency diseases or have a positive HIV test result at Screening.
Show all 39Show fewer
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 3 years of Screening, regardless of whether there is evidence of local recurrence or metastases.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs (apart from cholecystectomy), or which may jeopardize the participants in case of participation in the study. The investigator should make this determination in consideration of the participant's medical history and/or clinical or laboratory evidence of any of the following:
- Inflammatory bowel disease, peptic ulcers, gastrointestinal including rectal bleeding within 3 months prior to Screening.
- Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection.
- Pancreatic injury or pancreatitis.
- Healthy participants (Group 1):
- Any single parameter of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), or alkaline phosphatase (ALP) exceeding 1.2 × upper limit of normal (ULN) or ≥ 1.5 × ULN total bilirubin (TBL) OR any elevation above ULN of more than one parameter of ALT, AST, GGT, ALP, or serum bilirubin at screening.
- Known to have Gilbert's syndrome.
- Hemoglobin levels below 12.0 g/dL for males and 11.0 g/dL for females at Screening or Baseline.
- History or presence of impaired renal function as indicated by clinically significant abnormal creatinine or blood urea nitrogen (BUN) and/or urea values, or abnormal urinary constituents at Screening.
- Total white blood cell (WBC) count which falls outside the range of 3.5 to 10.7 × 109/L, or platelets < 100 × 109/L at Screening or Baseline.
- Evidence of urinary obstruction or difficulty in voiding at Screening.
- Symptomatic genital or urinary tract infection in the 4 weeks prior to dosing of study treatment or the presence of active urinary tract infection at Screening.
- Participants with mild and moderate HI (Groups 2 and 3):
- Have abnormal laboratory values for any of the following parameters at Screening or Baseline:
- Hemoglobin < 9 g/dL.
- Platelet count < 30 × 109/L.
- WBC count < 2.5 × 109/L.
- Absolute neutrophil count < 1.5 × 109/L.
- Lymphocytes < 0.8 × 109/L.
- TBL > 8 mg/dL.
- Serum amylase > 2 × ULN.
- International normalized ratio (INR) > 2.3
- Corrected serum calcium < 8.6 or > 10.2 mg/dL.
- Hepatic impairment due to non-liver disease.
- Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the participant at undue risk.
- Treatment with any vasodilator, autonomic alpha blocker or β2 agonist within 2 weeks prior to dosing of study treatment.
- Primary biliary cholangitis or biliary obstruction.
- Participants requiring paracentesis more than every 30 days for the management of ascites are excluded. Participants who are receiving diuretics to manage ascites may be enrolled and will be assigned the Child-Pugh score for the degree of ascites while on diuretic treatment. The diuretic dose must have been stable for 28 days prior to dosing of study treatment.
- Have transjugular intrahepatic portosystemic shunt and/or have undergone portacaval shunting.
- Have encephalopathy Grade 3 or worse within 28 days prior to dosing of study treatment.
- Presence of moderate to severe impaired renal function as indicated by estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 based on the modification of diet in renal disease calculation at Screening.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Novartis Investigative Site
Coral Gables, Florida, 33124
Novartis Investigative Site
Orlando, Florida, 32809
About this study
Official title: A Phase I, Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of FIA586 in Participants With Mild and Moderate Hepatic Impairment Compared to Matched Healthy Participants
This is a Phase I study designed to characterize the pharmacokinetics (PK), safety, and tolerability of a single oral dose of FIA586 in participants with mild and moderate hepatic impairment (HI) compared to matched healthy participants.The information obtained in this study will help to determine whether dosage adjustment for FIA586 is necessary in patients with advanced liver fibrosis who have mild to moderate HI.
Read the detailed description
This is a Phase I, single-dose, open-label, parallel-group study in participants with mild (Child-Pugh A; n=8-10) and moderate (Child-Pugh B; n=8-10) hepatic impairment (HI) and matched healthy participants with normal hepatic function (n=8-20).
The study is comprised of an up to 28-day screening period (Days -28 to 2), a baseline evaluation (Day -1) prior to dosing on Day 1, and a treatment period of 6 days (Days 1-6). Participants will remain domiciled up to Day 6 after the Study Completion procedures have been completed.
On Day 1, participants will be given a single dose of FIA586 following an overnight fast. PK (plasma and urine) and biomarker samples will be taken prior to dosing of study treatment and up to 120 hours (Day 6) post- dose. On Day 6, after the last PK sample has been taken, Study Completion assessments will be performed, and the participant will be discharged, provided there are no safety or tolerability concerns as judged by the investigator.
All participants will have a post-study safety contact conducted approximately 30 days after administration of study treatment.
- Conditions
- Hepatic Impairment
- Being tested
- FIA586
- Keywords
- Hepatic Impairment, NASH, Child-Pugh classification, FIA586
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIA586Drug
FIA586 capsule
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Healthy participants with normal hepatic function | Experimental | Each participant will receive a single dose of FIA586 Receives: Drug: FIA586 |
| Group 2: Participants with mild hepatic impairment | Experimental | Each participant will receive a single dose of FIA586 Receives: Drug: FIA586 |
| Group 3: Participants with moderate hepatic impairment | Experimental | Each participant will receive a single dose of FIA586 Receives: Drug: FIA586 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Blood Concentrations (Cmax) for FIA586
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.
Measured: 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
Area Under Plasma Concentration-time Curve from time zero to the last measurable concentration sampling time (AUClast) for FIA586
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.
Measured: 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
Area Under Plasma Concentration-time Curve from Time Zero Extrapolated to Infinity (AUC[0-inf]) for FIA586
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
Measured: 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
Area Under Plasma Concentration-time Curve from time 0 to 48 hours (AUC0-48h) for FIA586
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.
Measured: 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
Time to Reach Maximum Blood Concentrations (Tmax) for FIA586
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.
Measured: 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
Terminal Elimination Half-life (T1/2) for FIA586
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.
Measured: 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
Apparent Clearance (CL/F) of FIA586
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.
Measured: 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
Apparent volume of distribution during terminal elimination phase (Vz/F) of FIA586
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start10 Dec 2021
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993157
- Sponsor's protocol ID
- CFIA586A02101
- Status last verified
- Jun 2024
- First submitted
- 3 Aug 2021
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of FIA586 in Participants With Mild and Moderate Hepatic Impairment Compared to Matched Healthy Participants
- ClinicalTrials.gov ID
- NCT04993157
- Acronym / sponsor ID
- CFIA586A02101
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic Impairment, NASH, Child-Pugh classification, FIA586
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I study designed to characterize the pharmacokinetics (PK), safety, and tolerability of a single oral dose of FIA586 in participants with mild and moderate hepatic impairment (HI) compared to matched healthy participants.The information obtained in this study will help to determine whether dosage adjustment for FIA586 is necessary in patients with advanced liver fibrosis who have mild to moderate HI.
Detailed description
This is a Phase I, single-dose, open-label, parallel-group study in participants with mild (Child-Pugh A; n=8-10) and moderate (Child-Pugh B; n=8-10) hepatic impairment (HI) and matched healthy participants with normal hepatic function (n=8-20).
The study is comprised of an up to 28-day screening period (Days -28 to 2), a baseline evaluation (Day -1) prior to dosing on Day 1, and a treatment period of 6 days (Days 1-6). Participants will remain domiciled up to Day 6 after the Study Completion procedures have been completed.
On Day 1, participants will be given a single dose of FIA586 following an overnight fast. PK (plasma and urine) and biomarker samples will be taken prior to dosing of study treatment and up to 120 hours (Day 6) post- dose. On Day 6, after the last PK sample has been taken, Study Completion assessments will be performed, and the participant will be discharged, provided there are no safety or tolerability concerns as judged by the investigator.
All participants will have a post-study safety contact conducted approximately 30 days after administration of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Healthy participants with normal hepatic function | Experimental | Drug: FIA586Each participant will receive a single dose of FIA586 |
| Group 2: Participants with mild hepatic impairment | Experimental | Drug: FIA586Each participant will receive a single dose of FIA586 |
| Group 3: Participants with moderate hepatic impairment | Experimental | Drug: FIA586Each participant will receive a single dose of FIA586 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 to smoke no more than 5 cigarettes (or equivalent) per day, and maintain the same smoking status from Screening until the Study Completion (Day -28 to Day 6).
- Healthy participants (Group 1)
- Must be in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at Screening.
Key exclusion criteria (39 listed)
- Use of other investigational drugs within the last 30 days or 5 half-lives prior to dosing of study treatment, whichever is longer.
- Known history of, or current clinically significant arrhythmias. Have clinically significant ECG abnormality or history of long-QT syndrome.
- Myocardial infarction < 5 years prior to Screening.
- Recent (within the last 3 years of Screening) or recurrent history of autonomic dysfunction (e.g. recurrent episodes of fainting or palpitations).
- History of immunodeficiency diseases or have a positive HIV test result at Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIA586FIA586 capsule | Drug | Group 1: Healthy participants with normal hepatic function, Group 2: Participants with mild hepatic impairment, Group 3: Participants with moderate hepatic impairment |
Primary outcome
Maximum Observed Blood Concentrations (Cmax) for FIA586
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Results for CFIA586A02101 from the Novartis Clinical Trials websiteLink provided by the sponsor.
- Plain Lanuguage Trial SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FIA586 in people with Hepatic Impairment, run by Novartis Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Blood Concentrations (Cmax) for FIA586 (time frame: 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.