A Phase 1, Single-center, Open-label, 2-part, 2-treatment Period, 1-sequence, Cross-over, Drug-drug Interaction Study to Investigate the Effect of Erythromycin on SAR443820 (Part A) and the Effect of Itraconazole on SAR443820 (Part B) in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Part B: SAR443820: AUClast
研究概览
简要总结
This is a Phase 1, cross-over, 2-part study for pharmacokinetic (PK) assessment of SAR443820 when co-administered with cytochrome P450 3A4 (CYP3A4) inhibitors (erythromycin ethyl succinate (EES) in Part A and possibly itraconazole in Part B).
In Part A, the objective is to assess the effects of repeated administration of EES as CYP3A4 inhibitor, on the PK profile of a single oral dose of SAR443820 tablet in healthy male and female participants.
In Part B, the objective is to assess the effects of repeated administration of itraconazole on the PK profile of a single oral dose of SAR443820 capsule in healthy male participants.
Part A includes a screening period, Period 1 (SAR443820), a wash-out period and Period 2 (SAR443820 + EES). Part B includes a screening period, Period 1 (SAR443820), a wash-out period and Period 2 (SAR443820 + itraconazole). The washout period between single SAR443820 administration in Period 1 and the start of dosing with EES (Part A) or itraconazole (Part B) in Period 2 is at least 4 days.
The study duration is approximately 7 weeks for each Part A and Part B.
The treatment duration is:
- For SAR443820 (both Part A and Part B): 1 day in each Period; single dose of SAR443830 on Period 1 (P1)-Day 1 and on Period 2 (P2)-Day 6 for each Part.
- For EES (Part A): 9 days of treatment in Period 2 with P2-Day 1 starting at least 4 days after P1-Day 1.
- For itraconazole (Part B): the treatment duration lasts 11 days in Period 2 and it is fixed once the results of Part A are issued, P2-Day 1 starting at least 4 days after P1-Day 1.
详细描述
The study duration was approximately 7 weeks for each Part A and Part B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Part A: male or female participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent
- •Part B: male participant only must be 18 to 55 years of age inclusive, at the time of signing the informed consent
- •Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m^2, inclusive
- •Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
排除标准
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness - Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any non-live Covid-19 vaccine within the last 2 weeks before inclusion, any live attenuated vaccine within the last 28 days before inclusion and any other non-vaccine biological drugs given within 4 months before inclusion
- •Current enrollment in Part A (applicable for Part B) or past participation in previous clinical study on SAR443820
- •Positive result for hepatitis B, C or human immunodeficiency virus (HIV)
- •Positive result on urine drug screen
- •Positive urine alcohol test
- •Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 5 days before inclusion The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
研究组 & 干预措施
Part-A, Period-1
Single dose of SAR443820 tablet on Day 1
干预措施: SAR443820 (Drug)
Part-A, Period-2
Single dose of SAR443820 tablet on Day 6, and erythromycin ethyl succinate (EES) three-time a day (TID) from Day 1 to Day 9
干预措施: SAR443820 (Drug)
Part-A, Period-2
Single dose of SAR443820 tablet on Day 6, and erythromycin ethyl succinate (EES) three-time a day (TID) from Day 1 to Day 9
干预措施: Erythromycin ethyl succinate (Drug)
Part-B, Period-1
Single dose of SAR443820 capsule on Day 1
干预措施: SAR443820 (Drug)
Part-B, Period-2
Single dose of SAR443820 capsule on Day 6, and Itraconazole once daily (QD) from Day 1 to Day 11
干预措施: SAR443820 (Drug)
Part-B, Period-2
Single dose of SAR443820 capsule on Day 6, and Itraconazole once daily (QD) from Day 1 to Day 11
干预措施: Itraconazole (Drug)
结局指标
主要结局
Part B: SAR443820: AUClast
时间窗: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12
Part B: SAR443820: AUC
时间窗: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12
Part A: SAR443820: Area under the plasma concentration from time zero to the last concentration above the limit of quantification (AUClast)
时间窗: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10
Part A: SAR443820: Area under the plasma concentration (AUC)
时间窗: Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10
次要结局
- Part A: SAR443820: Time to reach Cmax (tmax)(Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10)
- Part A: SAR443820: Terminal half-life (t1/2z)(Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10)
- Part B: SAR443820: Cmax(Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12)
- Part B: SAR443820: tmax(Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12)
- Part B: SAR443820: t1/2z(Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 12)
- Part A: Erythromycin ethyl succinate concentrations(Period 2: Day 6 and Day 7)
- Part A: Erythromycin base concentration(Period 2: Day 6 and Day 7)
- Part B: Itraconazole: Cmax(Period 2: Day 6 and Day 7)
- Part B: Itraconazole: AUClast(Period 2: Day 6 and Day 7)
- Part B: Hydroxyitraconazole: Cmax(Period 2: Day 6 and Day 7)
- Part B: Hydroxyitraconazole: AUClast(Period 2: Day 6 and Day 7)
- Part A: number of participants with treatment emergent adverse events (TEAEs)(Period 1: Day 1 to Day 4; Period 2: Day 1 to Day 10 + 3 days of end of study (EOS) period)
- Part B: number of participants with TEAEs(Period 1: Day 1 to Day 4; Period 2: Day 1 to Day 12 + 8-10 days of end of study (EOS) period)
- Part A: SAR443820: Maximum plasma concentration observed (Cmax)(Period 1: Day 1 to Day 3; Period 2: Day 6 to Day 10)