A Single-centre, Open-label, Randomised, Single-dose Study to Evaluate the Effect of Pre- and Post-dose Meal Timings on the Pharmacokinetic Properties of Inno8 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- AUC0-∞: the area under the plasma Inno8 concentration-time curve from time 0 to infinity after a single oral dose
研究概览
简要总结
The purpose of this study is to test a new medicine called Inno8. The study will test how eating and drinking before and after taking Inno8 affects how well it is absorbed in the stomach. The study consists of four arms. Participants will take the study medicine after an overnight fast. How long participants will need to fast depends on which group participants are in. After taking the study medicine, participants will need to fast again. The study will last for up to 9.5 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-45 years (both inclusive) at the time of signing informed consent.
- •Body mass index between 18.5 and 29.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
- •Body weight between 60.0 and 100.0 kilogram (kg) (both inclusive) at screening.
- •Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •Factor VIII activity greater than or equal to (≥) 150 percentage (%) at screening.
- •Increased risk of thrombosis, e.g. known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis.
- •Any clinical signs or established diagnosis of venous or arterial thromboembolic disease.
- •Any of the thrombophilia markers listed below:
- •Lupus anticoagulant, anti-cardiolipin antibody Immunoglobulin G (IgG) and Immunoglobulin M (IgM) or anti-β2 glycoprotein I antibody (IgG and IgM) outside the normal laboratory range at screening.
- •Heterozygosity or homozygosity for the factor V Leiden mutation (G1691A) OR heterozygosity or homozygosity for the prothrombin mutation (G20210A) OR compound heterozygosity for the factor V Leiden (G1691A) and prothrombin mutation (G20210A).
- •Protein C, protein S or antithrombin below the lower normal laboratory range.
- •Any known coagulation disorders.
- •Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
研究组 & 干预措施
Reference dose
Participants will receive oral dose of NNC0442-0344 A.
干预措施: NNC0442-0344 A (Drug)
Group B
Participants will receive oral dose of NNC0442-0344 A.
干预措施: NNC0442-0344 A (Drug)
Group A
Participants will receive oral dose of NNC0442-0344 A.
干预措施: NNC0442-0344 A (Drug)
Group C
Participants will receive oral dose of NNC0442-0344 A.
干预措施: NNC0442-0344 A (Drug)
结局指标
主要结局
AUC0-∞: the area under the plasma Inno8 concentration-time curve from time 0 to infinity after a single oral dose
时间窗: From baseline (Day 1) to day 17
Measured as nanograms\*day per millilitre (ng\*day/mL).
次要结局
- Tmax: The time to maximum observed plasma Inno8 concentration after a single oral dose(From baseline (Day 1) to day 17)
- Number of treatment emergent adverse events(From time of dosing (Day 1) to day 36)
- Change in platelets(From baseline (Day 1) to day 36)
- Cmax: Maximum observed plasma Inno8 concentration after a single oral dose(From baseline (Day 1) to day 17)
- Change in D-dimer(From baseline (Day 1) to day 36)
- Change in prothrombin fragment 1 and 2(From baseline (Day 1) to day 36)
- Change in fibrinogen(From baseline (Day 1) to day 36)
- Change in FIX antigen(From baseline (Day 1) to day 36)
- Change in FX antigen(From baseline (Day 1) to day 36)