A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics and Safety of VIR-2218

V

Vir Biotechnology

Status and phase

Enrolling
Phase 1

Conditions

Renal Impairment

Treatments

Drug: VIR-2218

Study type

Interventional

Funder types

Industry

Identifiers

NCT05844228
VIR-2218-V108

Details and patient eligibility

About

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

Full description

Participants may be enrolled in Cohorts 1 and 2 in a non-randomized way.

Enrollment

32 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for All Participants:

  • Participants must have stable renal function as defined by less than 20% change in estimated glomerular filtration rate (eGFR) between the first and second screening sample with the first screening visit occurring within 28 days prior to dosing on Day 1 and the second screening visit occurring no more than 14 days apart, but at least 72 hours apart from the first.
  • Body mass index (BMI) within the range 18.5 to 35.0 kg/m2 at screening.
  • Female and Male participants must consent to follow contraception requirements
  • Capability of giving signed informed consent form

Inclusion Criteria: Additional Criteria Specific to Healthy Participants:

  • Must be in the opinion of the investigator, be in good health based upon medical history, vital signs, physical examination, and screening laboratory evaluations
  • Must have normal renal function as defined by eGFR ≥ 90 mL/min/1.73m2 based on the Modification of Diet in Renal Disease (MDRD) equation determined from the mean of two measurements of serum creatinine at screening.

Inclusion Criteria: Additional Criteria Specific to Participants with Renal Impairment

  • Participants must, in the opinion of the investigator, be sufficiently healthy for study participation based on medical history, physical examination, vital signs, and screening laboratory evaluations
  • Participants with RI must have chronic moderate or severe RI and be clinically stable per investigator assessment for at least 3 months prior to screening
  • Moderate RI as defined by eGFR level 30-59 mL/min/1.73m2 based on the MDRD equation, or
  • Severe RI as defined by eGFR level 15-29 mL/min/1.73m2 based on the MDRD equation

Exclusion Criteria: Criteria for All Participants

  • Any clinically significant medical condition or psychiatric condition that may interfere with study intervention
  • Participants with uncontrolled hypertension, asthma, and/or diabetes (Type I or II).
  • Participants with diabetes
  • Participants with any active malignancy
  • Participants with vasculitis or conditions associated with vasculitis.
  • Participants who have undergone major surgery within 12 months of screening
  • Participants with unstable cardiac functions, abnormality, or clinically significant heart failure
  • Participants with infection of HIV, HAV, HBV, HCV, HDV, or HEV
  • Participants with signs of active infection
  • History of bone marrow or solid organ transplantation
  • Participants with end-stage renal disease or nephrotic syndrome as defined by: participants requiring hemodialysis or peritoneal dialysis, participants who have undergone or are listed for transplant, or participants who have chronic kidney disease with nephrotic syndrome
  • Participants with active nephritis
  • Participants with clinically significant liver disease
  • History of drug or alcohol abuse
  • Unwillingness or inability to follow procedures outlined in protocol

Exclusion Criteria: Additional Criteria Specific to Healthy Participants

Use of any prescription medications or over-the-counter medications (with the exception of vitamins and/or hormonal contraceptive medications) including herbal products within 30 days prior to D1 of study participation

Exclusion Criteria: Additional Criteria Specific to Participants with Renal Impairment

Not on stable dose and regimen of any medication(s) (prescription or over-the-counter) that the participants is taking regularly (eg, medications for chronic conditions such as hypertension, high cholesterol, or depression must not be changed in dose or type for at least 2 weeks prior to study drug administration)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Cohort 1: 8 moderate Renal Impairment (RI) participants and 8 matched healthy participants
Experimental group
Treatment:
Drug: VIR-2218
Cohort 2: 8 severe Renal Impairment (RI) participants and 8 matched healthy participants (optional)
Experimental group
Treatment:
Drug: VIR-2218

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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