- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05760300
A Multiple-Dose Study of Bulevirtide in Participants With Normal and Impaired Renal Function
A Phase 1 Open-Label, Parallel-Design, Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Bulevirtide in Participants With Normal and Impaired Renal Function
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Gilead Clinical Study Information Center
- Phone Number: 1-833-445-3230 (GILEAD-0)
- Email: GileadClinicalTrials@gilead.com
Study Locations
-
-
Florida
-
Edgewater, Florida, United States, 32132
- Recruiting
- Velocity Clinical Research, New Smyrna Beach
-
Miami, Florida, United States, 33014
- Recruiting
- Clinical Pharmacology of Miami, LLC
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Miami, Florida, United States, 33147
- Recruiting
- Advanced Pharma CR, LLC
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Miami Lakes, Florida, United States, 33014
- Recruiting
- Panax Clinical Research
-
Miami Lakes, Florida, United States, 33016
- Recruiting
- Floridian Clinical Research, LLC
-
Saint Petersburg, Florida, United States, 33705
- Recruiting
- Global Clinical Professionals Research
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Tampa, Florida, United States, 33603
- Recruiting
- Genesis Clinical Research, LLC
-
-
Minnesota
-
Saint Paul, Minnesota, United States, 55114
- Recruiting
- Nucleus Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Key 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.
Key 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A: Bulevirtide (BLV), Severe Renal Impaired Participants
Participants with severe renal impairment will receive BLV 2 mg once daily for 6 days. Following completion and evaluation of pharmacokinetics (PK) and safety data from all participants in Group A, additional participant groups (Groups B, C, and D) and BLV doses (2 mg or 10 mg) may be initiated. |
Administered via subcutaneous (SC) injections
Other Names:
|
Experimental: Group A: BLV, Normal Renal Function (Matched Control Participants)
Participants with normal renal function will receive BLV 2 mg once daily for 6 days. Following completion and evaluation of PK and safety data from all participants in Group A, additional participant groups (Groups B, C, and D) and BLV doses (2 mg or 10 mg) may be initiated. |
Administered via subcutaneous (SC) injections
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic (PK) Parameter: AUCtau of Bulevirtide (BLV)
Time Frame: Day 6: Predose up to 24 hours postdose
|
AUCtau is defined as area under the concentration versus time curve over the dosing interval at steady state.
|
Day 6: Predose up to 24 hours postdose
|
PK Parameter: Cmax ss of BLV
Time Frame: Day 6: Predose up to 24 hours postdose
|
Cmax is defined as the maximum observed concentration of drug at steady state.
|
Day 6: Predose up to 24 hours postdose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK Parameter: AUC0-24 of BLV
Time Frame: Day 1: Predose up to 24 hours postdose
|
AUC0-24 is defined as the concentration of drug over time between time 0 hour and time 24 hours.
|
Day 1: Predose up to 24 hours postdose
|
PK Parameter: Cmax of BLV
Time Frame: Day 1: Predose up to 24 hours postdose
|
Cmax is defined as the maximum observed concentration of drug.
|
Day 1: Predose up to 24 hours postdose
|
PK Parameter: Tmax of BLV
Time Frame: Day 1 and Day 6: Predose up to 24 hours postdose
|
Tmax is defined as the time (observed time point) of Cmax.
|
Day 1 and Day 6: Predose up to 24 hours postdose
|
PK Parameter: t1/2 of BLV
Time Frame: Day 1: Predose up to 24 hours postdose and Day 6: Predose up to 48 hours postdose
|
t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
|
Day 1: Predose up to 24 hours postdose and Day 6: Predose up to 48 hours postdose
|
PK Parameter: CLss/F of BLV
Time Frame: Day 6: Predose up to 48 hours postdose
|
CLss/F is defined as the apparent clearance at steady state.
|
Day 6: Predose up to 48 hours postdose
|
PK Parameter: Vss/F of BLV
Time Frame: Day 6: Predose up to 48 hours postdose
|
Vss/F is defined as the apparent volume of distribution at steady state.
|
Day 6: Predose up to 48 hours postdose
|
PK Parameter: Ctrough of Total Bile Acids (BA)
Time Frame: Day 2 and Day 5 (predose), Day 7, and Day 8
|
Ctrough is defined as the concentration of total BA at the end of the dosing interval.
|
Day 2 and Day 5 (predose), Day 7, and Day 8
|
PK Parameter: Cmax of Total BA
Time Frame: Day 1 and Day 6: Predose up to 24 hours postdose
|
Cmax is defined as the maximum observed concentration of total BA.
|
Day 1 and Day 6: Predose up to 24 hours postdose
|
PK Parameter: AUC0-24 of Total BA
Time Frame: Day 1 and Day 6: Predose up to 24 hours postdose
|
AUC0-24 is defined as the concentration of total BA over time between time 0 hour and time 24 hours.
|
Day 1 and Day 6: Predose up to 24 hours postdose
|
PK Parameter: Tmax of Total BA
Time Frame: Day 1 and Day 6: Predose up to 24 hours postdose
|
Tmax is defined as the time (observed time point) of Cmax of total BA.
|
Day 1 and Day 6: Predose up to 24 hours postdose
|
Percentage of Participants With Treatment-Emergent Adverse Events
Time Frame: First dose date up to 6 days plus 7 days
|
First dose date up to 6 days plus 7 days
|
|
Percentage of Participants With Laboratory Abnormalities
Time Frame: First dose date up to 6 days plus 7 days
|
First dose date up to 6 days plus 7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Kidney Diseases
- Urologic Diseases
- Disease Attributes
- Liver Diseases
- Hepatitis, Viral, Human
- Hepatitis, Chronic
- Hepatitis
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Hepatitis D
- Hepatitis D, Chronic
- Renal Insufficiency
Other Study ID Numbers
- GS-US-589-6160
- 2022-502054-13-00 (Other Identifier: European Medicines Agency)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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