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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Area Under the Plasma Concentration Time Curve Extrapolated from Time 0 to Infinity (AUCinf) of BPN14770
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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%)
排除标准
- •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.
研究组 & 干预措施
Group 1: Mild HI
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.
干预措施: BPN14770 (Drug)
Group 2: Moderate HI
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.
干预措施: BPN14770 (Drug)
Group 3: Severe HI
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.
干预措施: BPN14770 (Drug)
Group 4: Normal Hepatic Function
Participants with normal hepatic function will receive a single oral dose of BPN14770 capsule on Day 1.
干预措施: BPN14770 (Drug)
结局指标
主要结局
Area Under the Plasma Concentration Time Curve Extrapolated from Time 0 to Infinity (AUCinf) of BPN14770
时间窗: Predose up to 240 hours postdose
Maximum Observed Plasma Concentration (Cmax) of BPN14770
时间窗: Predose up to 240 hours postdose
Time Maximum Observed Plasma Concentration (Tmax) of BPN14770
时间窗: Predose up to 240 hours postdose
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Up to 15 days postdose)