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Kidney disease may change how this drug works

NCT ID NCT07012005

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how the drug BPN14770 moves through the body in people with severe kidney problems compared to healthy people. Researchers measured drug levels in the blood and checked for side effects. The goal was to understand if kidney function affects how the drug is processed, not to treat kidney disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

14 people

The number who actually took part.

Started

Aug 2025

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 a. Severe renal impairment: eGFR \<30 milliliters (mL)/minute (min) * 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%) Exclusion Criteria: 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Division of Clinical Pharmacology, University of Miami

    Miami, Florida, 33136, United States

  • Orlando Clinical Research Center

    Orlando, Florida, 32809, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.