NCT02164266已完成1 期
A Study to Investigate in Healthy Volunteers (Part 1) and in Patients With Type 2 Diabetes Mellitus (Part 2) the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of RO6799477
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
- 40
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This study is designed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO6799477 following once daily oral administration for 2 weeks in healthy volunteers (Part 1) and in Type 2 diabetes patients (T2D) (Part 2). The anticipated time on study treatment is two 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part 1 Inclusion criteria:
- •Right-handed male volunteers
- •Aged 18-45 years, inclusive
- •Healthy participants, as determined by screening assessments and Principal Investigator's judgment
- •Healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis
- •Body Mass Index (BMI) of 18-30 kg/m2 inclusive, with body weight in the range of 50-100 kg
- •Part 2 Inclusion Criteria:
- •Patients with type 2 diabetes according to WHO criteria diagnosed for at least 3 months prior to screening
- •Male or female patients, 40 to 65 years of age, inclusive
- •Type 2 diabetic patients who are either drug naive (diet & exercise alone) or on a stable dose of metformin for at least 3 months prior to screening or willing to safely stop sulfonylurea medications at least 2 weeks prior to first dose administration and until follow-up visit
- •BMI of 23-42 kg/m2, inclusive
排除标准
- •Part 1 Exclusion criteria:
- •Any clinically relevant history or the presence of e.g. respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, etc. disease or diseases
- •Disorders of central nervous system, psychiatric disorders, behavioral disturbances (e.g. cerebrovascular events, depression, post-traumatic stress disorder [PTSD], anxiety, bipolar disorder, severe migraine, Parkinson's disease)
- •Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times per year
- •Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- •Part 2 Exclusion Criteria:
- •Type 1 diabetes
- •Acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes
- •Evidence or history of clinically significant diabetic complications such as clinically severe diabetic peripheral neuropathy, clinically significant nephropathy as judged by the investigator, or pre-proliferative/proliferative diabetic retinopathy as judged by the investigator or already diagnosed by the diabetologist or general practitioner
- •Disorders of central nervous system, psychiatric disorders, behavioral disturbances
- •Clinically significant history or presence of bronchopulmonary, gastrointestinal, hematological, lymphatic, neurological, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, infectious, connective tissue or inflammatory diseases, and any type of cancer (with the exception of treated basal cell carcinoma of the skin) or other clinically significant disease
- •Use of anti-diabetic drugs other than metformin or sulfonylureas within 2 months prior to screening
- •Any condition or disease detected during the medical interview / physical examination that would render the patient unsuitable for the study, place the patient at undue risk or interfere with the ability of the patient to complete the study in the opinion of the investigator
研究组 & 干预措施
Part 1: Healthy Volunteers
Experimental
干预措施: Placebo (Drug)
Part 1: Healthy Volunteers
Experimental
干预措施: RO6799477 (Drug)
Part 2: Patients with T2D, Group A
Experimental
Low dose daily oral administration of RO6799477
干预措施: Placebo (Drug)
Part 2: Patients with T2D, Group A
Experimental
Low dose daily oral administration of RO6799477
干预措施: RO6799477 (Drug)
Part 2: Patients with T2D, Group B
Experimental
High dose daily oral administration of RO6799477
干预措施: Placebo (Drug)
Part 2: Patients with T2D, Group B
Experimental
High dose daily oral administration of RO6799477
干预措施: RO6799477 (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: Up to 9 weeks
次要结局
- Pharmacokinetic parameters derived from plasma and urine concentrations of RO6799477, area under the concentration time curve (AUC), Cmax(Day 1 and Day 14)
- Fasting serum glucose(Up to 9 weeks)
- Fasting serum insulin (Part 2 only)(Up to 9 weeks)
研究者
相似试验
已完成
1 期
TMC278-TiDP15-C158 - A Study to Examine the Safety, Tolerability and Pharmacokinetics of a Single Dose or Three Successive Doses of Intramuscularly (IM) Injected Long Acting Formulation of TMC278HIV InfectionsNCT01031589Tibotec Pharmaceuticals, Ireland19
已完成
1 期
A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of MaravirocHIV InfectionHIV-1 InfectionMycobacterium Avium Complex (MAC)NCT01894776Ottawa Hospital Research Institute15
已完成
1 期
A Study in Healthy Volunteers to Evaluate Serum and Urine Levels of the Investigational Product Versus Comparator.HealthyNCT00280358Dey30
已完成
1 期
Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of of HZBio1 in Healthy SubjectsHealthy ParticipantsNCT04765995Hangzhou Grand Biologic Pharmaceutical, Inc.40
Unknown
1 期
to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy VolunteersParkinson's DiseaseNCT04593511Luye Pharma Group Ltd.40