Study of Bulevirtide in Participants Who Have Normal or Impaired Liver Function

NCT05765344 | Completed Phase 1 Results FDA Drug

• 1 other identifier: GS-US-589-6162
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 6

Brief Summary

The goals of this study are to measure the amount of bulevirtide (BLV) that gets into the blood stream and how long it takes to get rid of it, measure the effect of BLV on bile acids, and evaluate the safety and tolerability of multiple doses of BLV in participants with normal and impaired hepatic (liver) function.

Conditions

Hepatic Impairment; Healthy

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic (PK) Parameter: AUCtau of Bulevirtide (BLV)

  AUCtau was defined as the area under the concentration versus time curve (AUC) over the dosing interval at steady state.

  Day 6: Predose and up to 24 hours postdose

• PK Parameter: Cmax,ss of BLV

  Cmax,ss was defined as the maximum observed concentration of drug at steady state.

  Day 6: Predose and up to 24 hours postdose

Secondary Outcomes (13)

• PK Parameter: AUC0-24h of BLV

  Day 1: Predose and up to 24 hours postdose

• PK Parameter: Tmax of BLV

  Days 1 and 6: Predose and up to 24 hours postdose

• PK Parameter: Cmax of BLV

  Day 1: Predose and up to 24 hours postdose

• PK Parameter: t1/2 of BLV

  Day 6: Predose and up to 48 hours postdose

• PK Parameter: CLss/F of BLV

  Day 6: Predose and up to 48 hours postdose

Study Arms (8)

Group A: Bulevirtide (BLV) 2 mg, Moderate Hepatic Impairment

EXPERIMENTAL

Participants with moderate hepatic impairment will receive BLV 2 mg subcutaneous (SC) injection, once daily for 6 days starting on Day 1.

Drug: Bulevirtide

Group A: BLV 2 mg, Matched Control

EXPERIMENTAL

Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 2 mg SC injection once daily for 6 days starting on Day 1.

Drug: Bulevirtide

Group B: BLV 2 mg, Severe Hepatic Impairment

EXPERIMENTAL

Participants with severe hepatic impairment will receive BLV 2 mg SC injection, once daily for 6 days starting on Day 1.

Drug: Bulevirtide

Group B: BLV 2 mg, Matched Control

EXPERIMENTAL

Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 2 mg SC injection once daily for 6 days starting on Day 1.

Drug: Bulevirtide

Group C: BLV 10 mg, Moderate Hepatic Impairment

EXPERIMENTAL

Participants with moderate hepatic impairment will receive BLV 10 mg SC injection, once daily for 6 days starting on Day 1.

Drug: Bulevirtide

Group C: BLV 10 mg, Matched Control

EXPERIMENTAL

Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 10 mg SC injection once daily for 6 days starting on Day 1.

Drug: Bulevirtide

Group D: BLV 10 mg, Severe Hepatic Impairment

EXPERIMENTAL

Participants with severe hepatic impairment will receive BLV 10 mg SC injection, once daily for 6 days starting on Day 1.

Drug: Bulevirtide

Group D: BLV 10 mg, Matched Control

EXPERIMENTAL

Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 10 mg SC injection once daily for 6 days starting on Day 1.

Drug: Bulevirtide

Interventions

Bulevirtide DRUG

2 mg administered via subcutaneous injections.

Also known as: Hepcludex®, Myrcludex B

Group A: BLV 2 mg, Matched Control; Group A: Bulevirtide (BLV) 2 mg, Moderate Hepatic Impairment; Group B: BLV 2 mg, Matched Control; Group B: BLV 2 mg, Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All individuals:
• Body mass index (BMI) of 18 ≤ BMI ≤ 40 kg/m\^2 at screening.
• Have a calculated creatinine clearance (CLcr) of at least 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at screening.
• Individuals assigned male at birth and individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in the protocol.
• Individuals have not donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study drug.
• lead electrocardiogram (ECG) evaluations at screening must be without clinically significant abnormalities as assessed by the investigator.
• Aside from hepatic impairment among the individuals with hepatic impairment, the individual must, in the opinion of the investigator, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, and screening laboratory evaluations.
• Must be willing and able to comply with all study requirements.
• Individuals With Hepatic Impairment:
• Have a diagnosis of chronic (\> 6 months), stable hepatic impairment (moderate or severe based upon the Child-Pugh-Turcotte (CPT) classification system for moderate or severe hepatic impairment \[CPT Class B or C, respectively\]) with no clinically significant change in hepatic status (as determined by the investigator) within the 2 months (60 days) prior to screening.
• Individuals with moderate or severe hepatic impairment must have a score of 7 to 9 or 10 to 15 on the CPT classification system at screening. If an individual's score changes during the study, the score at screening will be used for classification.
• Must meet all of the following laboratory parameters at screening:
• alanine aminotransferase (ALT) ≤ 10 × upper limit of normal (ULN)
• aspartate aminotransferase (AST) ≤ 10 × ULN
• platelets ≥ 25,000/mm\^3

You may not qualify if:

• All Individuals:
• Positive serum pregnancy test at screening and at admission.
• Breastfeeding individual.
• Have received any study drug within 30 days prior to study dosing.
• Have current alcohol or substance abuse judged by the investigator to potentially interfere with individual compliance or individual safety, or a positive drug or alcohol test at screening or admission.
• Have poor venous access that limits phlebotomy.
• Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the study.
• Have a history of any of the following:
• Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria.
• Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity).
• Known hypersensitivity to the study drugs, their metabolites, or to formulation excipients.
• Significant cardiac disease (including history of myocardial infarction based on ECG and/or clinical history, any history of ventricular tachycardia, congestive heart failure, or dilated cardiomyopathy with left ventricular ejection fraction ≤ 40%); or a family history of long QT syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years.
• Syncope, palpitations, or unexplained dizziness.
• Implanted defibrillator or pacemaker.
• Have any serious or active medical or psychiatric illness (including depression).

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (6)

Orange County Research Center

Lake Forest, California, 92630, United States

Location

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Pinnacle Clinical Research LLC

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

• Kumar P, Mercier RC, Nieves W, Pan D, Tseng S, Chee GM, et al. Pharmacokinetics, Pharmacodynamics, and Safety of Bulevirtide 2 mg Once Daily for 6 Days in Participants With Moderate and Severe HI and in Matched Control Participants With Normal Hepatic Function. American Association for the Study of Liver Diseases (AASLD); 1154: 15 November 2024

  BACKGROUND

• Parag Kumar, Wildaliz Nieves, David Pan, Steve Tseng, Yuejiao Jiang, Yehong Wang, Ann Qin, Teckla Akinyi, Renee-Claude Mercier. Pharmacokinetics, Pharmacodynamics, and Safety of Bulevirtide 10 mg Once Daily for 6 Days in Participants With Moderate HI and in Matched Control Participants With Normal Hepatic Function. EASL - European Association for the Study of the Liver May 7-10, 2025 Amsterdam the Netherlands

  BACKGROUND

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

bulevirtide; myrcludex-B

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: March 15, 2023
• Primary Completion: January 10, 2025
• Study Completion: January 13, 2025
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)