A Phase 1, Open-Label, Single Dose Parallel-Group Study of Brensocatib Following a Single Oral Administration in Subjects With or Without Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Area Under the Plasma Concentration Time Curve (AUC) of Brensocatib
研究概览
简要总结
The primary purpose of the study is to determine the pharmacokinetics (PK) following a single oral dose administration of brensocatib, safety, and tolerability of brensocatib when administered to participants with impaired renal function and in healthy participants.
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
- •Has a body mass index (BMI) 18 to 35 kilograms per square meter (kg/m^2), inclusive, and a body weight of ≥50 kg at Screening.
- •Inclusion Criteria (for Participants With Renal Impairment):
- •Mild, moderate, or severe renal impairment as determined by estimated glomerular filtration rate (eGFR) and calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
- •Renal insufficiency or other related concomitant medical conditions (e.g., hypertension, anemia) has remained stable for at least 3 months before study drug dosing.
- •Inclusion Criteria for Healthy Participants:
- •Normal renal function as determined by eGFR and calculated using the CKD-EDI formula, or by 24-hour urine creatinine clearance (CLcr) corrected for body size.
- •In good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings.
排除标准
- •Positive test result for human immunodeficiency virus types 1 or 2 antibodies, hepatitis C virus antibodies, or hepatitis B surface antigen or hepatitis B core antibodies.
- •History of relevant drug and/or food allergies (i.e., allergy to brensocatib or any excipients, or any significant food allergy).
- •The participant has received study drug in another investigational study within 30 days of Screening.
- •Exclusion Criteria (for Participants With Renal Impairment):
- •Has nephrotic syndrome, defined as urine dipstick 4+ for protein and plasma albumin <3.0 grams per deciliter (g/dL), and then confirmed if proteinuria >5 g/day.
- •Has an extrarenal cause of renal impairment (e.g., rapidly growing, space occupying lesions, adrenal enlargement).
- •Has a functioning renal transplant (participant may be included in the study if he or she had a failed renal transplant and is not taking immunosuppressants).
- •Has a hemoglobin value less than 8.5 g/dL.
- •Has Type 1 or Type 2 diabetes mellitus.
- •Exclusion Criteria (for Healthy Participants):
- •Has used any prescription (excluding hormonal birth control, hormone replacement therapy, nonsteroidal anti-inflammatory drugs, or acetaminophen) or over-the-counter medications, including herbal or nutritional supplements, within 14 days before study drug dosing and throughout the study.
- •Note: Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
Cohort 1 (Mild Impairment): Brensocatib
Participants with mild renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.
干预措施: Brensocatib (Drug)
Cohort 2 (Moderate Impairment): Brensocatib
Participants with moderate renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.
干预措施: Brensocatib (Drug)
Cohort 3 (Severe Impairment): Brensocatib
Participants with severe renal impairment will receive single oral dose of brensocatib on Day 1 under fasted conditions.
干预措施: Brensocatib (Drug)
Cohort 4 (Normal): Brensocatib
Healthy participants with normal renal function will receive single oral dose of brensocatib on Day 1 under fasted conditions. Healthy participants will be matched within the protocol criteria to one or more participants with renal impairment.
干预措施: Brensocatib (Drug)
结局指标
主要结局
Area Under the Plasma Concentration Time Curve (AUC) of Brensocatib
时间窗: Pre-dose and at multiple timepoints post-dose on Days 1 to 14
Pharmacokinetics of brensocatib following a single dose will be assessed in participants with renal impairment and in healthy participants.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Brensocatib
时间窗: Pre-dose and at multiple timepoints post-dose on Days 1 to 14
Maximum Observed Plasma Concentration (Cmax) of Brensocatib
时间窗: Pre-dose and at multiple timepoints post-dose on Days 1 to 14
Number of Participants who Experienced at Least one Adverse Event (AE)
时间窗: Up to Day 14
Determination of the safety and tolerability of a single dose of brensocatib in participants with impaired renal function and in healthy participants.
次要结局
未报告次要终点