Renal ImpairmentPhase 1NCT07012005
Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls
A Phase 1 study testing BPN14770 in people with Renal Impairment, run by Shionogi at 2 sites in United States.
Trial summary
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of BPN14770 in participants with severe renal impairment and those with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal 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
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Aug 2025to 15 Dec 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Participants:
- Considered to be healthy (for healthy participants) or medically stable (for participants with renal impairment), as determined by medical evaluation including medical/surgical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram (ECG) during the screening period and upon admission to the clinical research unit (CRU).
- Body weight ≥ 50 kilograms (kg) and body mass index (BMI) within the range 18.5 to <40.0 kg/square meter (m^2) (inclusive)
- Participants With Renal Impairment:
- Participants that are not undergoing hemodialysis and have severe renal impairment based upon their 2021 chronic kidney disease epidemiology collaboration (CKD-EPI) creatinine formula creatinine clearance estimate (CLcr) estimated glomerular filtration rate (eGFR) estimate and the participant's body surface area (BSA) calculated at the screening visit
- Severe renal impairment: eGFR <30 milliliters (mL)/minute (min)
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- A stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of study intervention through the follow-up/early termination visit.
- Healthy Participants:
- Participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. Renal function, calculated by 2021 CKD-EPI creatinine formula and the participant's BSA, must be normal (that is, eGFR ≥90 mL/min)
- Matched to each participant with severe renal impairment with respect to sex, age (± 10 years), and BMI (± 10%)
Who cannot join
- All Participants:
- History or presence of/significant history of or current cardiovascular, respiratory, renal, gastrointestinal (GI), 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 judgement of the investigator
- Current or chronic history of liver disease or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones)
- History of GI surgery including but not limited to gastric resection and/or intestinal resection that resulted in a clinically significant abnormality in GI function
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- Participants with fluctuating or rapidly deteriorating renal function. Assessment of the stability of the participant's renal function will be determined by the investigator.
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- Any condition requiring medication and/or other treatment other than protocol-specified medication for participants with renal impairment, such as dietary restriction and physical therapy
- Participant with poor venous access
- History of Coronavirus Disease 2019 (COVID-19) infection within 14 days prior to the screening visit or admission to the CRU, or close contact with a COVID-19 patient in the 14 days prior to the screening visit or admission to the CRU as reported by the participant and the participant's medical history.
- Sensitivity to the study intervention, or components thereof, or a drug or other allergy, including food allergy, that in the opinion of the investigator or medical monitor contraindicates participation in the study.
- Participants With Renal Impairment:
- Participant with acute renal failure or a kidney transplant history or requiring renal dialysis during the study period
- Current or anticipated need for hemodialysis during the study
- NOTE: Other protocol-specified inclusion and exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Division of Clinical Pharmacology, University of Miami
Miami, Florida, 33136
Orlando Clinical Research Center
Orlando, Florida, 32809
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 Severe Renal Impairment and Healthy Control Participants
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of BPN14770 in participants with severe renal impairment and those with normal renal function.
- Conditions
- Renal Impairment
- Being tested
- BPN14770
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPN14770Drug
BPN14770 will be administered per schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Participants With Severe Renal Impairment | Experimental | Participants with severe renal impairment will receive a single dose of BPN14770 administered orally in the fasted state on Day 1. Receives: Drug: BPN14770 |
| Group 2: Participants With Normal Renal Function | Experimental | Participants with normal renal function will receive a single dose of BPN14770 administered orally in the fasted state on Day 1. Receives: Drug: BPN14770 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of BPN14770
Measured: 0 (predose) up to 240 hours postdose on Day 1 to Day 11
Time to Reach Cmax (Tmax) of BPN14770
Measured: 0 (predose) up to 240 hours postdose on Day 1 to Day 11
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of BPN14770
Measured: 0 (predose) up to 240 hours postdose on Day 1 to Day 11
Secondary outcomes (1)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start25 Aug 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012005
- Sponsor's protocol ID
- 2415A4113
- Status last verified
- Feb 2026
- First submitted
- 2 Jun 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 Severe Renal Impairment and Healthy Control Participants
- ClinicalTrials.gov ID
- NCT07012005
- Acronym / sponsor ID
- 2415A4113
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 10 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 purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of BPN14770 in participants with severe renal impairment and those with normal renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Participants With Severe Renal Impairment | Experimental | Drug: BPN14770Participants with severe renal impairment will receive a single dose of BPN14770 administered orally in the fasted state on Day 1. |
| Group 2: Participants With Normal Renal Function | Experimental | Drug: BPN14770Participants with normal renal function will receive a single dose of BPN14770 administered orally in the fasted state on Day 1. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Considered to be healthy (for healthy participants) or medically stable (for participants with renal impairment), as determined by medical evaluation including medical/surgical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram (ECG) during the screening period and upon admission to the clinical research unit (CRU).
- Body weight ≥ 50 kilograms (kg) and body mass index (BMI) within the range 18.5 to <40.0 kg/square meter (m^2) (inclusive)
- Participants that are not undergoing hemodialysis and have severe renal impairment based upon their 2021 chronic kidney disease epidemiology collaboration (CKD-EPI) creatinine formula creatinine clearance estimate (CLcr) estimated glomerular filtration rate (eGFR) estimate and the participant's body surface area (BSA) calculated at the screening visit
- A stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of study intervention through the follow-up/early termination visit.
- Participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. Renal function, calculated by 2021 CKD-EPI creatinine formula and the participant's BSA, must be normal (that is, eGFR ≥90 mL/min)
Key exclusion criteria (14 listed)
- History or presence of/significant history of or current cardiovascular, respiratory, renal, gastrointestinal (GI), 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 judgement of the investigator
- Current or chronic history of liver disease or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones)
- History of GI surgery including but not limited to gastric resection and/or intestinal resection that resulted in a clinically significant abnormality in GI function
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- Participants with fluctuating or rapidly deteriorating renal function. Assessment of the stability of the participant's renal function will be determined by the investigator.
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 |
|---|---|---|
| BPN14770BPN14770 will be administered per schedule specified in the arm description. | Drug | Group 1: Participants With Severe Renal Impairment, Group 2: Participants With Normal Renal Function |
Primary outcome
Maximum Plasma Concentration (Cmax) of BPN14770
Time frame: 0 (predose) up to 240 hours postdose on Day 1 to Day 11
Time to Reach Cmax (Tmax) of BPN14770
Time frame: 0 (predose) up to 240 hours postdose on Day 1 to Day 11
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of BPN14770
Time frame: 0 (predose) up to 240 hours postdose on Day 1 to Day 11
1 secondary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Day 15
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 BPN14770 in people with Renal Impairment, run by Shionogi 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 10 inclusion and 14 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 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?
Maximum Plasma Concentration (Cmax) of BPN14770 (time frame: 0 (predose) up to 240 hours postdose on Day 1 to Day 11). 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.