Hepatitis BPhase 1NCT04971928
Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment
A Phase 1 study testing GSK3228836 in people with Hepatitis B, run by GlaxoSmithKline at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- GSK3228836
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Sep 2021to 12 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Orlando, Florida, 32809
GSK Investigational Site
San Antonio, Texas, 78215
About this study
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)
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.
- Conditions
- Hepatitis B
- Being tested
- GSK3228836
- Keywords
- GSK3228836, Hepatitis B, Child-Pugh B (CP-B) cirrhosis, Child-Pugh A (CP-A) cirrhosis, Pharmacokinetics, B-Assured
- Medical subject headings
- Hepatitis B, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK3228836Drug
GSK3228836 will be administered
| Study group | Role | What they receive |
|---|---|---|
| Participants with Moderate (CP-B) hepatic impairment | Experimental | Not described Receives: Drug: GSK3228836 |
| Participants with Mild (CP-A) hepatic impairment | Experimental | Not described Receives: Drug: GSK3228836 |
| Healthy participants | Experimental | Not described Receives: Drug: GSK3228836 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)]
Measured: Up to Day 50 post-dose
Maximum observed concentration (Cmax)
Measured: Up to Day 50 post-dose
Secondary outcomes (7)
AUC from time zero (pre-dose) to 24 hours [AUC(0-24)]
Measured: Up to 24 hours post-dose
AUC from time zero (pre-dose) to 168 hours [AUC(0-168)]
Measured: Up to 168 hours post-dose
Plasma concentration of GSK3228836 on Day 8
Measured: Day 8 post-dose
Apparent terminal phase half-life (t1/2)
Measured: Up to Day 50 post-dose
Apparent clearance (CL/F)
Measured: Up to Day 50 post-dose
Time of occurrence of Cmax (Tmax)
Measured: Up to Day 50 post-dose
Apparent terminal phase volume of distribution (Vz/F)
Measured: Up to Day 50 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start7 Sep 2021
- Primary completion12 May 2022
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971928
- Sponsor's protocol ID
- 205871
- Status last verified
- Sep 2022
- First submitted
- 22 Jun 2021
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04971928
- Acronym / sponsor ID
- 205871
- Conditions
- Hepatitis B
- Keywords
- GSK3228836, Hepatitis B, Child-Pugh B (CP-B) cirrhosis, Child-Pugh A (CP-A) cirrhosis, Pharmacokinetics, B-Assured
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants with Moderate (CP-B) hepatic impairment | Experimental | Drug: GSK3228836 |
| Participants with Mild (CP-A) hepatic impairment | Experimental | Drug: GSK3228836 |
| Healthy participants | Experimental | Drug: GSK3228836 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK3228836GSK3228836 will be administered | Drug | Healthy participants, Participants with Mild (CP-A) hepatic impairment, Participants with Moderate (CP-B) hepatic impairment |
Primary outcome
Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)]
Time frame: Up to Day 50 post-dose
Maximum observed concentration (Cmax)
Time frame: Up to Day 50 post-dose
7 secondary outcomes
AUC from time zero (pre-dose) to 24 hours [AUC(0-24)]
Time frame: Up to 24 hours post-dose
AUC from time zero (pre-dose) to 168 hours [AUC(0-168)]
Time frame: Up to 168 hours post-dose
Plasma concentration of GSK3228836 on Day 8
Time frame: Day 8 post-dose
Apparent terminal phase half-life (t1/2)
Time frame: Up to Day 50 post-dose
Apparent clearance (CL/F)
Time frame: Up to Day 50 post-dose
Time of occurrence of Cmax (Tmax)
Time frame: Up to Day 50 post-dose
Apparent terminal phase volume of distribution (Vz/F)
Time frame: Up to Day 50 post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK3228836 in people with Hepatitis B, run by GlaxoSmithKline at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)] (time frame: Up to Day 50 post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.