Last updated: 09/24/2024 06:10:58
Phase 1 study of GSK3228836 pharmacokinetics in participants with hepatic impairment
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase 1, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics of GSK3228836 in Adults with Hepatic Impairment and Healthy Matched Control Participants (B-Assured)
Trial description: This is a Phase 1, open-label, parallel-group study to evaluate the pharmacokinetics of GSK3228836 in participants with Child-Pugh B (CP-B) cirrhosis (moderate hepatic impairment), Child-Pugh A (CP-A) cirrhosis (mild hepatic impairment) and participants with normal hepatic function as healthy control.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)]
Timeframe: Up to Day 50 post-dose
Maximum observed concentration (Cmax)
Timeframe: Up to Day 50 post-dose
Secondary outcomes:
AUC from time zero (pre-dose) to 24 hours [AUC(0-24)]
Timeframe: Up to 24 hours post-dose
AUC from time zero (pre-dose) to 168 hours [AUC(0-168)]
Timeframe: Up to 168 hours post-dose
Plasma concentration of GSK3228836 on Day 8
Timeframe: Day 8 post-dose
Apparent terminal phase half-life (t1/2)
Timeframe: Up to Day 50 post-dose
Apparent clearance (CL/F)
Timeframe: Up to Day 50 post-dose
Time of occurrence of Cmax (Tmax)
Timeframe: Up to Day 50 post-dose
Apparent terminal phase volume of distribution (Vz/F)
Timeframe: Up to Day 50 post-dose
Interventions:
Drug: GSK3228836
Enrollment:
24
Observational study model:
Not applicable
Primary completion date:
2022-12-05
Time perspective:
Not applicable
Clinical publications:
Nadia Noormohamed, Tamara Lukic, Thomas C Marbury, Eric J Lawitz, Holly Prescott, Mindy Magee, Ahmed Nader, Kelong Han. A Phase 1, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Bepirovirsen in Adults with Hepatic Impairment and Healthy Participants (B-Assured). Clinical pharmacology in drug development. 2024-Sep-13; doi:10.1002/cpdd.1454 http://dx.doi.org/10.1002/cpdd.1454
PMID: 39268699
DOI: 10.1002/cpdd.1454
Medical condition
Hepatitis B
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2021 to May 2022
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Body weight >50 Kilogram (kg) and body mass index (BMI) within the range 19 to 40 Kilogram per square meters (kg/m2) (inclusive)
- Capable of giving signed informed consent.
- Diagnosed or suspected hepatocellular carcinoma.
- History of malignancy within the past 5 years except for cancers that are cured by surgical resection (e.g., skin cancer).
Inclusion and exclusion criteria
Inclusion criteria:
- Body weight >50 Kilogram (kg) and body mass index (BMI) within the range 19 to 40 Kilogram per square meters (kg/m2) (inclusive)
- Capable of giving signed informed consent.
- Child-Pugh B cirrhosis (moderate hepatic impairment; Part 1) or Child-Pugh A cirrhosis (mild hepatic impairment; Part 2) or a healthy control participant based on a medical evaluation including medical history, physical examination (PE), laboratory tests.
Exclusion criteria:
- Diagnosed or suspected hepatocellular carcinoma.
- History of malignancy within the past 5 years except for cancers that are cured by surgical resection (e.g., skin cancer).
- History of vasculitis or presence of symptoms and signs of potential vasculitis or history/presence of other diseases that may be associated with vasculitis condition.
- Unstable cardiac function or high blood pressure that is not controlled (based on the investigator’s discretion).
- Any other medical condition which, in the judgment of the investigator and Medical Monitor, could jeopardize the integrity of the data derived from that participant or the safety of the participant.
- Participants who have taken or are currently taking any therapies not allowed by the protocol.
- A positive test for human immunodeficiency virus (HIV) antibody.
- History of sensitivity to GSK3228836 or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Trial location(s)
Location
GSK Investigational Site
Orlando, Florida, United States, 32809
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78215
Status
Study Complete
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2022-12-05
Actual study completion date
2022-12-05
Plain language summaries
Summary of results in plain language
Available language(s): English
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website