NCT01802853已完成1 期
Open Label, Randomized, 2 Way-crossover Study to Investigate the Absolute Bioavailability and Pharmacokinetics of RO6811135, Following Single Dose Administration by Subcutaneous and Intravenous Route in Healthy Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Absolute bioavailability of RO6811135 after subcutaneous administration: Area under the concentration-time curve (AUC)
研究概览
简要总结
This open-label, randomized, 2-way crossover study will assess the absolute bioavailability and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B) RO6811135, with a washout period of at least 7 days between dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Male healthy volunteers, 18-45 years of age inclusive
- •Healthy as determined by screening assessments
- •Body mass index (BMI) between 18-30 kg/m2
排除标准
- •Any clinically relevant history or the presence of respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological or connective tissue disease or diseases
- •History of anaphylaxis or severe systemic hypersensitivity or allergic reactions
- •Any history of alcohol and/or drug of abuse addiction during the past 5 years
- •Smoking more than 5 cigarettes a day or the equivalent amount of tobacco
- •Any clinically relevant abnormal test results prior to first dosing
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Participation in an investigational drug or device study within 3 months prior to Day -1 of Period 1
研究组 & 干预措施
A: RO6811135 s.c.
Experimental
干预措施: RO6811135 (Drug)
B: RO6811135 i.v.
Active Comparator
干预措施: RO6811135 (Drug)
结局指标
主要结局
Absolute bioavailability of RO6811135 after subcutaneous administration: Area under the concentration-time curve (AUC)
时间窗: 48 hours
次要结局
- Safety: Incidence of adverse events(approximately 5 weeks)
- Pharmacodynamics: Fasting serum glucose/serum insulin(48 hours)
- Nausea scale: Visual analogue scale(48 hours)
研究者
相似试验
已完成
1 期
A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid TumoursBreast Cancer, Colorectal CancerNCT01493336Hoffmann-La Roche37
已完成
1 期
Absolute Oral Bioavailability of RemimazolamBioavailabilityNCT04113564Paion UK Ltd.14
已完成
1 期
A Study to Compare the Bioavailability of JNJ-47910382 Formulated as a Tablet and as Suspension in Healthy ParticipantsHealthy ParticipantsNCT01662661Janssen R&D Ireland14
已完成
1 期
Relative Bioavailability of Two Tepotinib Film-Coated Tablet Formulations in Healthy VolunteersHealthyNCT03021642Merck KGaA, Darmstadt, Germany24
Unknown
1 期
Comparative Bioavailability Study of Omexa Sumatriptan vs. Imitrex® in Healthy VolunteersMigraineNCT02954276Targia Pharmaceuticals Ltd.13