jRCT2031200170已完成不适用
AN 8-WEEK PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF TWICE DAILY PF-06882961 ADMINISTRATION IN JAPANESE ADULTS WITH TYPE 2 DIABETES MELLITUS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Basic Science
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 70age old under（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Patients with T2DM who are treated with diet and exercise
- •HbA1c greater than or equal to 7% and less than or equal to 10.5%
- •Total body weight >50 kg (110 lb) with BMI 22.5 to 45.4 kg/m^2
排除标准
- •Exclusion Criteria:
- •Any condition possibly affecting drug absorption
- •Diagnosis of Type 1 diabetes
- •History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening
- •Any malignancy not considered cured
- •Personal or family history of MTC or MEN2, or participants with suspected MTC
- •Acute pancreatitis or history of chronic pancreatitis
- •Symptomatic gallbladder disease
- •Known medical history of active proliferative retinopathy and/or macular edema
- •Known history of HIV, hepatitis B, hepatitis C or syphilis
- •Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
- •Clinically relevant ECG abnormalities
- •Positive urine drug test
研究者
相似试验
进行中（未招募）
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children with Hemodynamically Significant Congenital Heart DiseaseEUCTR2005-001671-35-GBMedImmune, Inc.1,235
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants with Systemic Lupus Erythematosus2023-509188-26-00F. Hoffmann-La Roche AG7
进行中（未招募）
不适用
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children with Hemodynamically Significant Congenital Heart Disease.EUCTR2007-002070-61-SEMedImmune LLC800
进行中（未招募）
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children with Hemodynamically Significant Congenital Heart Disease.EUCTR2007-002070-61-CZMedImmune, LLC800
进行中（未招募）
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children with Hemodynamically Significant Congenital Heart Disease.Serious respiratory syncytial virus (RSV) disease in children with hemodynamically significant congential heart disease (CHD).MedDRA version: 9.0Level: PTClassification code 10061603Term: <Manually entered code. Term in E.1.1>EUCTR2007-002070-61-PLMedImmune, Inc.1,235