Hepatic ImpairmentPhase 1NCT07018492
Phase 1 Study of BPN14770 in Participants With Hepatic Impairment and Healthy Controls
A Phase 1 study testing BPN14770 in people with Hepatic Impairment, run by Shionogi at 3 sites in United States.
Trial summary
The primary purpose of this study is to assess the pharmacokinetics (PK) of BPN14770 after a single oral administration of BPN14770 in participants with mild, moderate, and severe liver impairment compared with control participants with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- BPN14770
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Aug 2025to 26 Nov 2025
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Considered to be healthy (for healthy participants) or medically stable (for participants with hepatic impairment), as determined by medical evaluation.
- Body weight ≥ 50 kilograms (kg) and body mass index (BMI) within the range ≥ 18.5 to < 40.0 kilograms per square meter (kg/m^2).
- A diagnosis of clinically stable hepatic disease for at least 1 month prior to the screening visit, confirmed by medical history or previous confirmation of hepatic cirrhosis by liver biopsy or medical imaging technique.
- Mild, moderate, and severe hepatic impairment based on the Child-Pugh classification score at the screening visit and Day ˗1 to determine eligibility:
- Mild (Class A) hepatic impairment (Child-Pugh classification score 5 to 6)
- Moderate (Class B) hepatic impairment (Child-Pugh classification score 7 to 9)
- Severe (Class C) hepatic impairment (Child-Pugh classification score 10 to 15)
- Healthy Participants matched to each participant with moderate hepatic impairment with respect to sex, age (± 10 years), and BMI (± 10%)
Who cannot join
- History or presence of/significant history of or current cardiovascular, respiratory, hepatic, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data, in the judgment of the investigator.
- Blood loss or blood donation that exceeds 500 milliliters (mL) within 56 days prior to or at the screening visit or donation of any amount of blood from the screening visit until admission to the clinical research unit (CRU).
- Healthy participants:
- Clinical laboratory values outside the reference range during the screening period or on Day ˗1 and considered clinically significant by the investigator
- Alanine aminotransferase or aspartate aminotransferase > 1.5 * the upper limit of normal (ULN) or bilirubin ≥ 1.0 * the ULN.
- Participants with hepatic impairment:
- Participant with clinically significant laboratory values in the opinion of the investigator or outside the acceptable ranges or limits during the screening period.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Division of Clinical Pharmacology, University of Miami
Miami, Florida, 33136
Orlando Clinical Research Center
Orlando, Florida, 32809
Texas Liver Institute
San Antonio, Texas, 78215
About this study
Official title: A Phase 1, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of BPN14770 in Participants With Mild, Moderate, and Severe Hepatic Impairment and Healthy Control Participants
The primary purpose of this study is to assess the pharmacokinetics (PK) of BPN14770 after a single oral administration of BPN14770 in participants with mild, moderate, and severe liver impairment compared with control participants with normal hepatic function.
- Conditions
- Hepatic Impairment
- Being tested
- BPN14770
- Keywords
- Mild Hepatic Impairment (HI), Moderate HI, Severe HI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPN14770Drug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Mild HI | Experimental | Participants with mild hepatic impairment who have a Child Pugh classification system score of Class A will receive a single oral dose of BPN14770 capsule on Day 1. Receives: Drug: BPN14770 |
| Group 2: Moderate HI | Experimental | Participants with moderate hepatic impairment who have a Child Pugh classification system score of Class B will receive a single oral dose of BPN14770 capsule on Day 1. Receives: Drug: BPN14770 |
| Group 3: Severe HI | Experimental | Participants with severe hepatic impairment who have a Child Pugh classification system score of Class C will receive a single oral dose of BPN14770 capsule on Day 1. Receives: Drug: BPN14770 |
| Group 4: Normal Hepatic Function | Experimental | Participants with normal hepatic function will receive a single oral dose of BPN14770 capsule on Day 1. Receives: Drug: BPN14770 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Time Curve Extrapolated from Time 0 to Infinity (AUCinf) of BPN14770
Measured: Predose up to 240 hours postdose
Maximum Observed Plasma Concentration (Cmax) of BPN14770
Measured: Predose up to 240 hours postdose
Time Maximum Observed Plasma Concentration (Tmax) of BPN14770
Measured: Predose up to 240 hours postdose
Secondary outcomes (1)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 15 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start30 Aug 2025
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by ShionogiThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Shionogi Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018492
- Sponsor's protocol ID
- 2414A4112
- Status last verified
- Feb 2026
- First submitted
- 5 Jun 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of BPN14770 in Participants With Mild, Moderate, and Severe Hepatic Impairment and Healthy Control Participants
- ClinicalTrials.gov ID
- NCT07018492
- Acronym / sponsor ID
- 2414A4112
- Conditions
- Hepatic Impairment
- Keywords
- Mild Hepatic Impairment (HI), Moderate HI, Severe HI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 12 Jun 2025 (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.
The primary purpose of this study is to assess the pharmacokinetics (PK) of BPN14770 after a single oral administration of BPN14770 in participants with mild, moderate, and severe liver impairment compared with control participants with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Mild HI | Experimental | Drug: BPN14770Participants with mild hepatic impairment who have a Child Pugh classification system score of Class A will receive a single oral dose of BPN14770 capsule on Day 1. |
| Group 2: Moderate HI | Experimental | Drug: BPN14770Participants with moderate hepatic impairment who have a Child Pugh classification system score of Class B will receive a single oral dose of BPN14770 capsule on Day 1. |
| Group 3: Severe HI | Experimental | Drug: BPN14770Participants with severe hepatic impairment who have a Child Pugh classification system score of Class C will receive a single oral dose of BPN14770 capsule on Day 1. |
| Group 4: Normal Hepatic Function | Experimental | Drug: BPN14770Participants with normal hepatic function will receive a single oral dose of BPN14770 capsule on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Considered to be healthy (for healthy participants) or medically stable (for participants with hepatic impairment), as determined by medical evaluation.
- Body weight ≥ 50 kilograms (kg) and body mass index (BMI) within the range ≥ 18.5 to < 40.0 kilograms per square meter (kg/m^2).
- A diagnosis of clinically stable hepatic disease for at least 1 month prior to the screening visit, confirmed by medical history or previous confirmation of hepatic cirrhosis by liver biopsy or medical imaging technique.
- Mild, moderate, and severe hepatic impairment based on the Child-Pugh classification score at the screening visit and Day ˗1 to determine eligibility:
- Healthy Participants matched to each participant with moderate hepatic impairment with respect to sex, age (± 10 years), and BMI (± 10%)
Key exclusion criteria (8 listed)
- History or presence of/significant history of or current cardiovascular, respiratory, hepatic, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data, in the judgment of the investigator.
- Blood loss or blood donation that exceeds 500 milliliters (mL) within 56 days prior to or at the screening visit or donation of any amount of blood from the screening visit until admission to the clinical research unit (CRU).
- Healthy participants:
- Participants with hepatic impairment:
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| BPN14770Administered as specified in the treatment arm. | Drug | Group 1: Mild HI, Group 2: Moderate HI, Group 3: Severe HI, Group 4: Normal Hepatic Function |
Primary outcome
Area Under the Plasma Concentration Time Curve Extrapolated from Time 0 to Infinity (AUCinf) of BPN14770
Time frame: Predose up to 240 hours postdose
Maximum Observed Plasma Concentration (Cmax) of BPN14770
Time frame: Predose up to 240 hours postdose
Time Maximum Observed Plasma Concentration (Tmax) of BPN14770
Time frame: Predose up to 240 hours postdose
1 secondary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 15 days postdose
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 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Medical Director study director
Shionogi Inc.
3 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 BPN14770 in people with Hepatic Impairment, run by Shionogi at 3 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 8 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 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Plasma Concentration Time Curve Extrapolated from Time 0 to Infinity (AUCinf) of BPN14770 (time frame: Predose up to 240 hours postdose). The study lists 3 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 Feb 2026.