A Phase 1, Randomized, Open-label Study to Characterize the Effect of Food on the Oral Bioavailability of a Prolonged-release Formulation of Vamifeport in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of vamifeport
研究概览
简要总结
This is a phase I, single-center, randomized, open-label, single-dose, 2-way, 2-period, crossover study to evaluate the effect of food on the pharmacokinetics (PK) of vamifeport prolonged-release (PR) formulation in healthy adult participants. Participants will be randomly allocated to one of two treatment sequences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- ••Aged greater than or equal to (>=) 18 to less than or equal to (<=) 60 years at the time of providing written informed consent.
- ••Healthy, as determined by the investigator based on review of defined assessments during Screening.
- ••Body weight between 50 and 100 kilogram (kg) (inclusive) and body mass index within the range 18.0 to 30.0 kg per square metre (kg/m2) (inclusive) at Screening and Day - 1.
排除标准
- ••Any clinically relevant abnormal means of triplicate 12-lead ECG finding at Screening or Day - 1 (as deemed by the investigator).
- ••Serum ferritin of less than (<) 30 nanograms per milliliter (ng/mL) or greater than (>) 300 ng/mL for assigned male at birth (AMAB) participants or < 16 ng/mL or > 300 ng/mL for assigned female at birth (AFAB) participants at Screening or Day -
- ••Hemoglobin < 13 gram per deciliter (g/dL) (8.1 millimole per liter [mmol/L]) for AMAB participants or < 12 g/dL (7.5 mmol/L) for AFAB participants at Screening or Day -
- ••Blood draw or donation of blood (>= 450 mL) within 3 months before Screening, plasma donation from 2 weeks before Screening, or platelet donation from 6 weeks before Screening.
研究组 & 干预措施
Sequence 1: Vamifeport Fasted then Fed
In sequence 1, eligible participants assigned to sequence 1 will receive a single vamifeport dose on an empty stomach on Day 1 (fasted condition), undergo a washout period, and then receive a single vamifeport dose after a standardized high-fat meal (fed condition) on Day 6.
干预措施: Vamifeport (PR formulation) (Drug)
Sequence 2: Vamifeport Fed then Fasted
In sequence 2, eligible participants assigned to sequence 2 will receive a single vamifeport dose after a standardized high-fat meal on Day 1 (fed condition), undergo a washout period, and then receive a single vamifeport dose on an empty stomach (fasted condition) on Day 6.
干预措施: Vamifeport (PR formulation) (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of vamifeport
时间窗: 0-96 hours after dose
AUC from time zero extrapolated to infinity (AUC0-inf) of vamifeport
时间窗: 0-96 hours after dose
Maximum observed plasma concentration (Cmax) of vamifeport
时间窗: 0-96 hours after dose
次要结局
- Number of participants with treatment emergent adverse events (TEAEs) overall, by severity, seriousness, and relationship to vamifeport(Up to Day 13 (+/- 2 days))
- Percentage of participants with TEAEs overall, by severity, seriousness, and relationship to vamifeport(Up to Day 13 (+/- 2 days))
- Number of participants with clinically significant changes from baseline in clinical laboratory safety tests (biochemistry, hematology, and urinalysis), 12-lead electrocardiogram (ECG), and vital signs, reported as TEAEs(Up to Day 13 (+/- 2 days))
- Percentage of participants with clinically significant changes from baseline in clinical laboratory safety tests (biochemistry, hematology, and urinalysis), 12-lead ECG, and vital signs, reported as TEAEs(Up to Day 13 (+/- 2 days))
- Time of the maximum observed plasma concentration (Tmax) of vamifeport(0-96 hours after dose)
- Apparent terminal disposition phase plasma half life (t1/2) of vamifeport(0-96 hours after dose)
- Apparent terminal disposition rate constant (λz) of vamifeport(0-96 hours after dose)
- Apparent total clearance (CL/F) of vamifeport(0-96 hours after dose)
- Apparent volume of distribution (V/F) of vamifeport(0-96 hours after dose)
- Percentage of AUC due to extrapolation from the last quantifiable concentration to infinity (%AUCextrap) of vamifeport(0-96 hours after dose)
- Time of the last quantifiable concentration (Tlast) of vamifeport(0-96 hours after dose)
- The time taken for vamifeport to appear in the systemic circulation following administration (Tlag), when applicable(0-96 hours after dose)
- AUC from time zero to 12 hours (AUC0-12) and 24 hours (AUC0-24) of vamifeport(0-12 hours post-dose and 0-24 hours after dose)
- Plasma concentration of vamifeport(At 12 hours and 24 hours after dose)