CTRI/2011/04/001661招募中1 期
A placebo-controlled, randomized, rising multiple dose study of ADV-1002401 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in adult male Type-II diabetic subjects - NI
Advinus Therapeutics Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Non-smoking, male diabetics aged between 18 and 60 years (including both) with BMI between 20 to 36 kg/m2 (including both).
- •2.T2DM diagnosed subjects (with minimum of 6 months) who are not adequately controlled with metformin will only be enrolled in the study.
- •3.Fasting blood glucose of 125 to 220 mg/dL.
- •4.Successful completion of treatment-free washout period of ¡Ý 2 weeks from current metformin medications.
- •5.HbA1c greater than or equal to 7%, and less than or equal to 10.5%.
- •6.C-peptide 0.81 ng/mL at screening.
- •7.Otherwise normal health (exceptions stated in Section 12.0) as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
- •8.Clinically acceptable 12-lead electrocardiogram (ECG).
- •9.Clinically acceptable chest X-Ray (P/A view).
- •10.Negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- •11.Negative alcohol breath test.
- •12.Willingness to adhere to the protocol requirements and to provide written informed consent.
排除标准
- •The subjects will be excluded from the study, if they meet any of the following criteria:
- •1.Hypersensitivity to anti-diabetic or related drugs.
- •2.History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine disorders other than T2DM, immunological, dermatological, neurological or psychiatric disease or disorder.
- •3.Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
- •4.Use of any prescribed medication during last two weeks or OTC medicinal products (including herbal preparations) during the last one week prior to initiation of study.
- •5.Use of Pravastatin within 2 weeks prior to receiving ADV-1002401.
- •6.History or presence of significant alcoholism or drug abuse in the past one year (Appendix VIII from DSM-IV).
- •7.History or presence of smoking or use of other tobacco, pan, gutkha products since last 06 months.
- •8.History or presence of significant asthma, urticaria or other allergic reactions.
- •9.History or presence of significant gastric and/or duodenal ulceration.
- •10.History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
- •11.History or presence of cancer.
- •12.Difficulty with donating blood.
- •13.Major illness during 3 months before screening.
- •14.Participation in a drug research study within past 3 months.
- •15.Donation of blood in the past 3 months before screening.
- •16.Inability to consume 250 mL of fluid (150 mL buffered vehicle pH 7.4 followed by 100 mL of water) without emesis and discomfort.
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