The main aim of this study is to learn how the body processes fazirsiran (pharmacokinetics \[PK\]) in people with mild, moderate, or severe liver problems, compared to people with normal liver function. The study will include participants with liver scarring (cirrhosis) and mild, moderate, or severe liver problems, and participants with normal liver function. All participants will be given 1 injection of fazirsiran and will be followed up for 6 months after the fazirsiran injection.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Fazirsiran SC injection
CRU Hungary Kft
Kistarcsa, Hungary
Summit Clinical Research s.r.o.
Bratislava, Slovakia
Summit Clinical Research s.r.o.
Malacky, Slovakia
Summit Clinical Research s.r.o.
Nové Zámky, Slovakia
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Fazirsiran
Time frame: From pre-dose up to Month 6 post-dose
Area Under the Plasma Concentration-time Curve from Time 0 to Infinity (AUC0-inf) for Fazirsiran
Time frame: From pre-dose up to Month 6 post-dose
Maximum Observed Plasma Concentration (Cmax) for Fazirsiran
Time frame: From pre-dose up to Month 6 post-dose
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From the first dose of study drug up to end of follow-up (up to 6 months)
Number of Participants With Clinically Significant Abnormal Values for Laboratory Parameters
Time frame: From the first dose of study drug up to end of follow-up (up to 6 months)
Number of Participants With Clinically Significant Abnormal Values for Vital Signs Parameters
Time frame: From the first dose of study drug up to end of follow-up (up to 6 months)
Number of Participants With Clinically Significant Abnormal Values for Electrocardiogram (ECG) Parameters
Time frame: From the first dose of study drug up to end of follow-up (up to 6 months)
Number of Participants With Clinically Significant Abnormal Values for Pulmonary Function Parameters
Time frame: From the first dose of study drug up to end of follow-up (up to 6 months)
Number of Participants With Injection Site Reaction
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Time frame: From the first dose of study drug up to end of follow-up (up to 6 months)
Amount of Drug Excreted in Urine From Time 0 to Time 24 hours (Ae0-24hrs) for Fazirsiran
Time frame: Pre-dose, 0 to 24 hours post-dose
Amount of Drug Excreted in Urine From Time 0 to Time 6 hours (Ae0-6hrs) for Fazirsiran
Time frame: Pre-dose, 0 to 6 hours post-dose
Amount of Drug Excreted in Urine From Time 6 to Time 24 hours (Ae6-24h) for Fazirsiran
Time frame: From 6 to 24 hours post-dose
Percent of Recovered Drug in Urine Compared With the Dose (%Dose [u])
Time frame: Pre-dose, 0 to 24 hours post-dose
Renal Clearance (CLr) for Fazirsiran
Time frame: Pre-dose, 0 to 24 hours post-dose
Absolute Change in Serum Alpha-1 Antitrypsin (AAT) at Nadir
Time frame: From Day 1 Pre-dose Baseline up to end of follow-up (up to 6 months)
Percentage Change in Serum AAT at Nadir
Time frame: From Day 1 Pre-dose Baseline up to end of follow up (up to 6 months)
Absolute Change in Serum AAT
Time frame: From Day 1 Pre-dose Baseline and at Days 15, 29, 57
Percentage Change in Serum AAT
Time frame: From Day 1 Pre-dose Baseline and at Days 15, 29, 57