Health TrialsbyHealthPanel

Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434

ConditionsHepatic ImpairmentCirrhosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorVir Biotechnology, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Must in the opinion of the Investigator, be in good health based upon medical history, vital signs, physical examination, and screening laboratory evaluations

Disqualifiers

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 interfere with the safety of the participant

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 hepatitis E virus (HEV). HCV antibody positive participants with a negative HCV RNA are eligible. HDV antibody positive participants with a negative HDV RNA are eligible

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 participants at screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • VIR-2218

    Drug

    VIR-2218 given by subcutaneous injection.

  • VIR-3434

    Drug

    VIR-3434 given by subcutaneous injection.

Treatment groups

144 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Cohort 1: CPT-B (moderate HI) participants and matched healthy participants will be evaluated firstExperimental treatment 1 intervention
Group B: Cohort 2: CPT-C (severe HI) participants and matched healthy participantsExperimental treatment 1 intervention
Group C: Cohort 3: CPT-A (mild HI) participants and matched healthy participantsExperimental treatment 1 intervention
Group D: Cohort 4: CPT-A (mild HI) participants and matched healthy participantsExperimental treatment 1 intervention
Group E: Cohort 5: CPT-B (moderate HI) participants and matched healthy participantsExperimental treatment 1 intervention
Group F: Cohort 6: CPT-C (severe HI) participants and matched healthy participantsExperimental treatment 1 intervention
Group G: Cohort 7: CPT-A (mild HI) and matched healthy participantsExperimental treatment 2 interventions
Group H: Cohort 8: CPT-B (moderate HI) and matched healthy participantsExperimental treatment 2 interventions
Group I: Cohort 9: CPT-C (severe HI) and matched healthy participantsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximum observed Plasma concentration (Cmax) of VIR-2218 and metabolite AS(N-1)3'VIR2218

Time frame
5 days
2

Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-2218 and metabolite AS(N-1)3'VIR2218

Time frame
5 days
3

Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-2218 metabolite AS(N-1)3'VIR2218

Time frame
5 days
4

Maximum observed Plasma concentration (Cmax) of VIR-3434

Time frame
18 weeks

Secondary outcomes

1

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Time frame
Up to 18 Weeks
2

Incidence of ADA and titers of ADA to VIR-3434 at each study visit for cohorts receiving VIR-3434 therapy

Time frame
18 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vir Biotechnology, Inc.

Lead sponsor

Source ClinicalTrials.gov
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