study of bpn14770 in participants with severe renal impairment and healthy controls

Conditions: Renal Impairment

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.


Eligibility criteria:
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.