A Three-Part Phase 1 Study to Determine the Potential Drug Interaction Between ACH-0144471 and Midazolam, Fexofenadine and Mycophenolate Mofetil in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Part 1: Midazolam Area Under The Plasma Concentration-time Curve From Time 0 To The Time Of The Last Observed Non-zero Concentration (AUC0-t) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan
研究概览
简要总结
The purpose of this study was to determine the potential drug interaction between danicopan (ACH-0144471) and midazolam, fexofenadine, and mycophenolate mofetil. This was a 3-part study, with each part being an open-label, fixed-sequence, 2-treatment study in healthy adult 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
- Basic Science
- 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
- •Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
- •Body mass index of 18.5 to 32 kilograms (kg)/square meter with a minimum body weight of 50 kg.
排除标准
- •Mentally or legally incapacitated or significant emotional problems.
- •Any condition that might interfere with drug absorption.
- •History of sensitivity to study medication or other drug allergies.
- •Body temperature greater than or equal to 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 14 days of the first dose.
- •Positive urine drug test; current tobacco/nicotine users and smokers; consumption of alcohol within 72 hours of study drug administration.
- •Participated in another clinical study within 28 days prior to the first dose.
- •Significant laboratory abnormalities.
- •Blood donation of more than 500 milliliters within 3 months of the first dose; received a blood transfusion or blood products within 6 months to the first dose.
研究组 & 干预措施
Part 1: Danicopan and Midazolam
Period 1: Participants received a single dose of midazolam.
Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of midazolam.
Scheduled pharmacokinetics (PK) blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2.
干预措施: Danicopan (Drug)
Part 1: Danicopan and Midazolam
Period 1: Participants received a single dose of midazolam.
Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of midazolam.
Scheduled pharmacokinetics (PK) blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2.
干预措施: Midazolam (Drug)
Part 2: Danicopan and Fexofenadine
Period 1: Participants received a single dose of fexofenadine.
Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of fexofenadine.
Scheduled PK blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2.
干预措施: Danicopan (Drug)
Part 2: Danicopan and Fexofenadine
Period 1: Participants received a single dose of fexofenadine.
Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of fexofenadine.
Scheduled PK blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2.
干预措施: Fexofenadine (Drug)
Part 3: Danicopan and MMF
Period 1: Participants received a single dose of MMF.
Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of MMF.
Scheduled PK blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2.
干预措施: Danicopan (Drug)
Part 3: Danicopan and MMF
Period 1: Participants received a single dose of MMF.
Period 2: Participants received multiple doses of danicopan, in addition to coadministration with a single dose of MMF.
Scheduled PK blood samples were collected, with a washout period of at least 3 days between the dose in Period 1 and the first dose in Period 2.
干预措施: Mycophenolate Mofetil (Drug)
结局指标
主要结局
Part 1: Midazolam Area Under The Plasma Concentration-time Curve From Time 0 To The Time Of The Last Observed Non-zero Concentration (AUC0-t) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan
时间窗: Up to 24 hours postdose
Part 1: Midazolam Area Under The Plasma Concentration-time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan
时间窗: Up to 24 hours postdose
Part 1: Midazolam Maximum Observed Plasma Concentration (Cmax) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan
时间窗: Up to 24 hours postdose
Part 1: Midazolam Time To Reach Maximum Observed Plasma Concentration (Tmax) Following Single-dose Midazolam Alone Versus In The Presence of Steady-state Danicopan
时间窗: Up to 24 hours postdose
Part 2: Fexofenadine AUC0-t Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
时间窗: Up to 72 hours postdose
Part 2: Fexofenadine AUC0-inf Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
时间窗: Up to 72 hours postdose
Part 2: Fexofenadine Cmax Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
时间窗: Up to 72 hours postdose
Part 3: Mycophenolic Acid (MPA) and Mycophenolic Acid Glucuronide (MPAG) AUC0-t Following Single-dose Mycophenolate Mofetil (MMF) Alone Versus In The Presence of Steady-state Danicopan
时间窗: Up to 72 hours postdose
Part 3: MPA and MPAG AUC0-inf Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan
时间窗: Up to 72 hours postdose
Part 3: MPA and MPAG Tmax Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan
时间窗: Up to 72 hours postdose
Part 2: Fexofenadine Tmax Following Single-dose Fexofenadine Alone Versus In The Presence of Steady-state Danicopan
时间窗: Up to 72 hours postdose
Part 3: MPA and MPAG Cmax Following Single-dose MMF Alone Versus In The Presence of Steady-state Danicopan
时间窗: Up to 72 hours postdose
次要结局
- Parts 1-3: Participants Experiencing Treatment-emergent Adverse Events(7 (±1) days following the last dose in Period 2)