EUCTR2009-010720-26-EE进行中（未招募）不适用
A Phase II, Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Type 2 Diabetic Human Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 225
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects of any race and gender within the age range of 30 to 70 years.
- •2. All female subjects must be of non-child-bearing potential. For the purposes of this
- •study, this is defined as the subject being amenorrheic for at least 12 consecutive
- •months or at least 6 weeks post-surgical bilateral oophorectomy with or without
- •hysterectomy or women who underwent tubal ligation. Menopausal status will be
- •confirmed by demonstrating levels of follicle stimulating hormone (FSH) 40 – 138
- •mIU/ml and oestradiol < 20 pg/ml at entry, unless this information is available in the
- •subject’s medical record. In the event a subject's menopause status has been clearly
- •established (for example, the subject indicates she has been amenorrheic for 10
- •years), but FSH and/or oestradiol levels are not consistent with a post-menopausal
- •condition, determination of subject eligibility will be at the discretion of the principal
- •investigator following consultation with the sponsor and independent medical
- •3. All male subjects must agree with their partners to use double-barrier birth control or abstinence while participating in the study and for 12 weeks following the last dose of study drug.
- •4. Willingness to provide written informed consent to participate in the study
- •5. HbA1c = 7.5 and = 10.5
- •6. Fasting glucose = 160 and = 240 mg/dL
- •7. Body Mass Index (BMI) = 25.0 kg/m2 and = 40.0 kg/m2
- •8. On stable metformin medication for at least 3 months (= 1.0 g/day) prior to
- •9. No prior history of HIV 1 or 2
- •10. Absence of disease markers for hepatitis B & C virus
- •11. Absence of significant disease or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during the
- •screening; normal end organ function
- •12. Have a normal 12-lead ECG or one with abnormality considered to be clinically
- •insignificant
- •13. Have a normal chest X-ray (P. A. View) or one with abnormality considered to be
- •clinically insignificant
- •14. Comprehension of the nature and purpose of the study and compliance with the
- •requirement of the entire protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any major illness in the past three months or any significant ongoing chronic medical illness not related to diabetes
- •2. Renal or liver impairment, defined as serum creatinine level of = 1.4 mg/dL for
- •females and = 1.5 mg/dL for males, and greater than two times the upper limit of
- •normal for liver enzymes, respectively.
- •3. History of or current gastro-intestinal diseases influencing drug absorption, except for appendectomy
- •4. History, within 3 years, of drug abuse (including Benzodiazepines, opioids,
- •amphetamine, cocaine, and THC)
- •5. History of alcoholism (more than two years), moderate drinkers (more than three
- •drinks per day) or having consumed alcohol within 48 hrs prior to dosing [one drink
- •is equal to one unit of alcohol (one glass wine, half pint beer, one measure of spirit)]
- •6. Participation in any clinical trial within the past three months
- •7. History of difficulty in donating blood or accessibility of veins in left or right arm
- •8. Donation of blood (one unit or 350 ml) within three months prior to receiving the first dose of test material
- •9. Use of any prescription drug therapy, with exception of any prescription medication
- •administered at a stable dose for at least 6 weeks prior to Screening, provided the
- •medication is not contraindicated by the metformin label
- •10. Use of any alternate anti-diabetic therapy, except metformin, within three months of enrollment.
研究者
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