A Phase 1, Two-Part, Open-Label Drug-Drug Interaction Study to Evaluate the Steady State Pharmacokinetics and Safety Following Co-Administration of Nalbuphine Extended-Release Tablets (NAL ER), and Pirfenidone or Nintedanib in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of NAL ER, Pirfenidone, and Nintedanib
研究概览
简要总结
The primary purpose of this study is to evaluate the effect of steady-state NAL ER on the pharmacokinetics (PK) of pirfenidone or nintedanib and the effect of steady-state pirfenidone or nintedanib on the PK of NAL ER 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kilogram per meter square (kg/m^2) at Screening.
- •Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.
排除标准
- •Positive results for coronavirus infection (COVID-19).
- •History or presence of alcohol or drug abuse.
- •Positive urine drug or alcohol results.
- •Smoker who has used nicotine containing products within the last 3 months.
- •History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- •Hemoglobin, absolute neutrophil count, or platelet levels outside of the reference range at Screening.
- •History of prolonged QT syndrome or a QTc interval.
- •Abnormal liver function at Screening or historical or concurrent liver disease.
- •Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- •Abnormal Estimated glomerular filtration rate (eGFR).
- •History of difficulty donating blood or donation of blood or plasma within 56 days of Screening.
- •Participation in another clinical study within 30 days of the baseline visit.
- •[Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.]
研究组 & 干预措施
Cohort A1 - NAL ER + Pirfenidone
Participants will receive NAL ER followed by NAL ER co-administered with pirfenidone.
干预措施: NAL ER (Drug)
Cohort A1 - NAL ER + Pirfenidone
Participants will receive NAL ER followed by NAL ER co-administered with pirfenidone.
干预措施: Pirfenidone (Drug)
Cohort A2 - NAL ER + Nintedanib
Participants will receive NAL ER followed by NAL ER co-administered with nintedanib.
干预措施: NAL ER (Drug)
Cohort A2 - NAL ER + Nintedanib
Participants will receive NAL ER followed by NAL ER co-administered with nintedanib.
干预措施: Nintedanib (Drug)
Cohort B1 - Pirfenidone + NAL ER
Participants will receive pirfenidone followed by pirfenidone co-administered with NAL ER.
干预措施: NAL ER (Drug)
Cohort B1 - Pirfenidone + NAL ER
Participants will receive pirfenidone followed by pirfenidone co-administered with NAL ER.
干预措施: Pirfenidone (Drug)
Cohort B2 - Nintedanib + NAL ER
Participants will receive nintedanib followed by nintedanib co-administered with NAL ER.
干预措施: NAL ER (Drug)
Cohort B2 - Nintedanib + NAL ER
Participants will receive nintedanib followed by nintedanib co-administered with NAL ER.
干预措施: Nintedanib (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of NAL ER, Pirfenidone, and Nintedanib
时间窗: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Time to Reach Maximum Observed Concentration (Tmax) of NAL ER, Pirfenidone, and Nintedanib
时间窗: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-Tlast) of NAL ER, Pirfenidone, and Nintedanib
时间窗: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NAL ER, Pirfenidone, and Nintedanib
时间窗: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Apparent Terminal Rate Constant (λz) of NAL ER, Pirfenidone, and Nintedanib
时间窗: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Apparent Terminal Half-Life (t1/2) of NAL ER, Pirfenidone, and Nintedanib
时间窗: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Apparent Clearance (CL/F) of NAL ER, Pirfenidone, and Nintedanib
时间窗: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Apparent Volume of Distribution (Vz/F) of NAL ER, Pirfenidone, and Nintedanib
时间窗: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
次要结局
- Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Up to Day 21)
- Number of Participants With Clinically Significant Abnormalities in Vital Signs(Up to Day 21)