Study Details

PROTOCOL SUMMARY

The goals of this study are to compare the amount of study drug, bulevirtide (BLV), that gets into the bloodstream and how long it takes for the body to eliminate it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal or impaired renal (kidney) function.

Participation Requirements

Age

18 Years - 79 Years

Sex

ALL

Healthy Volunteers

true

Medical Condition

Chronic Hepatitis D Infection

Gender

N/A

Date

March 2023 - July 2024

Study Type

INTERVENTIONAL

Study Phase

PHASE1

Product

Bulevirtide (BLV)

Eligibility Information

Inclusion Criteria

All Individuals:
Body mass index (BMI) of at least ≥ 18.0 kg/m^2 and ≤ 40.0 kg/m^2 at screening.
No clinically significant abnormalities on electrocardiogram (ECG)
No known Liver Disease (Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)) ≤ 3 x upper limit of normal (ULN) at screening.
Individuals with Renal Impairment (RI):
Have RI classification at screening that has been unchanged during the 90 days prior to study drug dosing.
Estimated Glomerular Filtration Rate (eGFR) must be the following (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Inker 2021)) based on serum creatinine as measured at the screening evaluation:
Severe RI (Groups A and B): eGFR ≥ 15 to ≤ 29 mL/min/1.73 m^2
Moderate RI (Group C): eGFR ≥ 30 to ≤ 59 mL/min/1.73 m^2
Mild RI (Group D): eGFR ≥ 60 to ≤ 89 mL/min/1.73 m^2
Hemoglobin ≥ 9 g/dL at screening.
Individuals with cardiovascular disease, hypertension, diabetes mellitus, hyperlipidemia, hypothyroidism, osteoporosis, and many others) may be included provided that these diseases/conditions are clinically stable.
Matched Control Individuals:
Have an eGFR of at least 90 mL/min/1.73 m^2 (using the CKD-EPI equation) based on serum creatinine as measured at screening evaluation.
Matched for sex, age (± 10 years), and BMI (± 20%, 18.0 ≤ BMI ≤ 40.0 kg/m^2) with the respective participant in the RI group.

Exclusion Criteria

All Individuals:
Positive human immunodeficiency virus (HIV) test, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody with detectable HCV viral ribonucleic acid (RNA) at screening.
Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with participant treatment, assessment, or compliance with the protocol.
Individuals with RI:
Recent history of reception of any blood or blood products or history of major bleeding within 4 weeks of dosing.
Positive test for drugs of abuse, including alcohol at screening or admission, with the exception of opioids and tetrahydrocannabinol (THC, marijuana) under prescription and verified by the investigator as for pain management.
Received treatment with trimethoprim or cimetidine or tenofovir prodrugs (tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF)) (affects elimination of creatinine) or with competitors of renal tubular excretion (eg, probenecid, chronic high-dose nonsteroidal anti-inflammatory drugs) within 28 days of Day -1.
Received known nephrotoxic drugs (eg, aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, pentamidine, cyclosporine, tacrolimus, herbal remedies (eg, compounds with aristolochic acid)) within 28 days of Day -1.
Individuals requiring or anticipated to require dialysis within 90 days of study entry.
Serum albumin concentration <25 g/L.
Uncontrolled treated/untreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg); current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg).
Matched Control Individuals:
Have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins
Note: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

Locations (9)

Velocity Clinical Research, New Smyrna Beach

Edgewater, Florida, United States, 32132

Clinical Pharmacology of Miami, LLC

Miami, Florida, United States, 33014

Advanced Pharma CR, LLC

Miami, Florida, United States, 33147

Panax Clinical Research

Miami Lakes, Florida, United States, 33014

Floridian Clinical Research, LLC

Miami Lakes, Florida, United States, 33016

Global Clinical Professionals Research

St. Petersburg, Florida, United States, 33705

Genesis Clinical Research, LLC

Tampa, Florida, United States, 33603

Massachusetts General Hospital - Renal Associates Clinic

Boston, Massachusetts, United States, 02114

Nucleus Network

Saint Paul, Minnesota, United States, 55114

A Multiple-Dose Study of Bulevirtide in Participants With Normal and Impaired Renal Function

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