Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls

Shionogi

Status and phase: Not yet enrolling; Phase 1

Conditions: Renal Impairment

Treatments: Drug: BPN14770

Study type: Interventional

Funder types: Industry

Identifiers

NCT07012005

2415A4113

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Group 1: Participants With Severe Renal Impairment

Experimental group

Description:

Participants with severe renal impairment will receive a single dose of BPN14770 administered orally in the fasted state on Day 1.

Treatment:

Drug: BPN14770

Group 2: Participants With Normal Renal Function

Experimental group

Description:

Participants with normal renal function will receive a single dose of BPN14770 administered orally in the fasted state on Day 1.

Treatment:

Drug: BPN14770