VIR-2218 for Kidney Impairment

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vir Biotechnology, Inc.

Must not be taking: Antidepressants, Antihypertensives, Statins, others

Disqualifiers: Diabetes, Hypertension, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

28 Participants Needed

Trial Summary

What is the purpose of this trial?

The rationale of this study is to evaluate the impact of renal function on the PK, safety, and tolerability of VIR-2218 in participants with normal renal function and participants with varying degrees of renal dysfunction who are otherwise medically stable

Will I have to stop taking my current medications?

If you are a healthy participant, you must stop taking any prescription or over-the-counter medications (except vitamins and hormonal contraceptives) 30 days before the study. If you have renal impairment, you must be on a stable dose of your current medications for at least 2 weeks before starting the study.

Eligibility Criteria

This trial is for adults who are in good health or have stable moderate to severe kidney impairment, with specific eGFR levels. They must not have uncontrolled hypertension, diabetes, significant heart issues, active infections including HIV and hepatitis viruses, cancer, or a history of organ transplants. Participants should not be on certain medications before the study and must agree to use contraception.

Inclusion Criteria

My kidney function has been stable recently.

My kidney function is normal, with an eGFR of 90 or above.

I agree to follow the study's birth control requirements.

Exclusion Criteria

I have had a bone marrow or organ transplant.

I have severe kidney disease or am on dialysis.

I haven't taken any medications except vitamins or birth control in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of VIR-2218 to evaluate pharmacokinetics and safety

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• VIR-2218

Trial Overview The study tests VIR-2218's effects on people with different levels of kidney function. It aims to understand how well the drug works (pharmacokinetics) and its safety across participants with normal kidneys versus those with varying degrees of renal dysfunction.

Participant Groups

Group I: Cohort 2: 8 severe Renal Impairment (RI) participants and 8 matched healthy participants (optional) Experimental Treatment 1 Intervention

Group II: Cohort 1: 8 moderate Renal Impairment (RI) participants and 8 matched healthy participants Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Vir Biotechnology, Inc.

Lead Sponsor

Trials

30

Recruited

13,300+