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Tests treatment safety and results for Hepatic Impairment
Official title Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
ClinicalTrials.gov ID: NCT05484206
What this study is testing
What is VIR-2218?
VIR-2218 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hepatic impairment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this study, a single dose of VIR-2218 up to 200 mg SC or VIR-3434 at 300 mg SC monotherapy or a combination of VIR-2218 and VIR-3434 will be administered to assess the pharmacokinetic (PK) exposure, safety, and tolerability of VIR-2218 and VIR-3434 in participants with cirrhosis and Hepatic Impairment, defined using the Child-Pugh-Turcotte (CPT) categorization.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Must be ≥18 to ≤70 years of age at screening
- Must have a calculated BMI from 18.5 ≤ BMI ≤ 40 kg/m2
- All participants must have an eGFR ≥ 60 mL/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation Healthy matched participants
- Must in the opinion of the Investigator, be in good health based upon medical history, vital signs, physical examination, and screening laboratory...
- Apart from hepatic insufficiency, participants must, in the opinion of the Investigator be sufficiently healthy for study participation based on...
You likely can't join if
- Participants with unstable cardiac function or evidence of previous myocardial infarction in the past 12 months or any clinically significant active...
- Any clinically significant conduction abnormality or arrhythmia (including non-sustained or sustained ventricular tachycardia as per Investigator's...
- Infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), HBV (positive HBsAg or positive hepatitis B core antibody with negative...
- Systolic BP is outside the range of 90-160 mmHg, or diastolic BP is outside the range of 45-95 mmHg or heart rate is outside the range of 50-100...
- Use of any prescription medications or over-the-counter medications (with the exception of vitamins and/or hormonal contraceptive medication) within...
- Not on stable dose and regimen of any medication
See the full eligibility criteria
- Must be ≥18 to ≤70 years of age at screening
- Must have a calculated BMI from 18.5 ≤ BMI ≤ 40 kg/m2
- All participants must have an eGFR ≥ 60 mL/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation Healthy matched participants
- Must in the opinion of the Investigator, be in good health based upon medical history, vital signs, physical examination, and screening laboratory evaluations Hepatic impaired participants
- Apart from hepatic insufficiency, participants must, in the opinion of the Investigator be sufficiently healthy for study participation based on medical history, physical examination, vital signs, and screening...
- Participant is considered to have chronic, stable moderate, severe, mild HI (of any etiology excluding chronic HBV and HDV) and has been clinically stable per Investigator assessment for at least 1 month prior to...
- CPT score of 5 to 6 for mild HI at screening
- CPT score 7-9 for moderate HI at screening
- CPT score 10-15 severe HI at screening
- Participants with unstable cardiac function or evidence of previous myocardial infarction in the past 12 months or any clinically significant active cardiovascular disease that, in the opinion of the Investigator, could...
- Any clinically significant conduction abnormality or arrhythmia (including non-sustained or sustained ventricular tachycardia as per Investigator's assessment)
- Infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), HBV (positive HBsAg or positive hepatitis B core antibody with negative hepatitis B surface antibody), hepatitis C virus (HCV), HDV or...
- Systolic BP is outside the range of 90-160 mmHg, or diastolic BP is outside the range of 45-95 mmHg or heart rate is outside the range of 50-100 beats per minute (bpm) for female participants or 45-100 bpm for male...
- Use of any prescription medications or over-the-counter medications (with the exception of vitamins and/or hormonal contraceptive medication) within 30 days prior to D1 of study participation Exclusion criteria...
- Not on stable dose and regimen of any medication
- Acute or worsening chronic hepatitis
- Participants requiring paracentesis more than once a month
- Participants with refractory encephalopathy or significant Central Nervous System
- History of gastric or esophageal variceal bleeding within the past 6 months
- Participants with Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement
- Presence of hepatopulmonary or hepatorenal syndrome
- Presence of primarily cholestatic liver diseases
- History of or currently listed for liver transplantation
The study team makes the final eligibility decision.
Where it's taking place
- Rialto, California, United States
- Tustin, California, United States
- Hollywood, Florida, United States
- Miami Lakes, Florida, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rialto, California, United States; Tustin, California, United States; Hollywood, Florida, United States; Miami Lakes, Florida, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.