EUCTR2020-003280-26-GB进行中（未招募）1 期
A Dose-Ranging Pharmacodynamic Study to Evaluate the Effects of IMB-1018972 on Myocardial Energetics, Metabolism, and Function in Patients with Type 2 Diabetes - To evaluate IMB-1018972 on cardiac energetics in patients with T2D.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Provision of written informed consent before any screening procedures;
- •2. Male or female aged =18 and =75 years at screening;
- •3. Must agree to adequate contraception requirements as follows:
- •a. WOCBP must have a negative serum pregnancy test at screening and a negative pregnancy test (serum or urine) on the day of baseline pre-dose (Stage 1 and Stage 2), at Visit 5 pre dose (Stage 2 only), and at the end of study (EOS)/safety follow-up visit or early termination (Stage 1 and Stage 2);
- •b. WOCBP must agree to use dual methods of contraception, including 1 highly effective and 1 effective method of contraception, from the day of first dosing until 3 months after the last administration of test product; and
- •c. Male patients must use an effective barrier method of contraception if sexually active with a WOCBP, from the day of first dosing until 3 months after the last administration of test product;
- •4. Must agree not to donate sperm or ova from the day of first dosing until 3 months after last dosing;
- •5. Women not of childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before screening) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years with follicle-stimulating hormone (FSH) in the postmenopausal range at screening;
- •6. Must be able and willing to comply with all study procedures and requirements.
- •7. Diagnosis of T2D;
- •8. Elevated HbA1c defined as =6.5% (=48 mmol/mol);
- •9. Elevated BMI defined as =30 kg/m2;
- •10. Preserved LVEF (defined as =50%); and
- •11. If on oral hypoglycaemic (anti-diabetic) therapy, no change in therapy over the past 3 months.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •1. BMI >40 kg/m2;
- •2. Uncontrolled hypertension (defined as resting blood pressure >180/90 mmHg) at screening;
- •3. Standard contraindication(s) to magnetic resonance scanning;
- •4. More than mild to moderate valvular heart disease per Investigator’s judgement;
- •5. Persistent or permanent atrial fibrillation;
- •6. History of sustained ventricular tachycardia or cardiac arrest;
- •7. Exertional angina or intermittent claudication;
- •8. Known significant obstructive coronary artery disease per Investigator’s judgement;
- •9. Absolute or significant contraindication to dobutamine infusion, including: phaeochromocytoma, LV outflow tract obstruction, untreated hyperthyroidism, severe hypotension, aortic dissection, or large aneurysm;
- •10. History of stroke, transient ischaemic attack, acute coronary syndrome, myocardial infarction, peripheral vascular disease, diagnosis of NYHA functional class III or IV heart failure, hospitalization for heart failure, or any arterial revascularisation procedure (including coronary artery bypass grafting) within 6 months before screening;
- •11. Presence of indwelling cardiac device (pacemaker, cardiac resynchronisation therapy, and/or implantable cardioverter defibrillator);
- •12. Significant hepatic impairment defined as total bilirubin and/or alanine aminotransferase and/or aspartate aminotransferase >2 x upper limit of the normal;
- •13. Moderate or severe renal impairment defined as estimated glomerular filtration rate <60 mL/min/1.73 m2 of body surface area;
- •14. History of Parkinson disease, Parkinsonian symptoms, restless leg syndrome, or other related movement disorders;
- •15. Known allergy, intolerance, or absolute contraindication to TMZ or nicotinic acid;
- •16. Concomitant use within the last 1 month of TMZ, nicotinic acid (at prescription/therapeutic dose), perhexiline, meldonium, or ranolazine;
- •17. Any use of insulin and/or SGLT2 inhibitors;
- •18. History of alcohol abuse or drug addiction within the previous 5 years;
- •19. Pregnant, or planning pregnancy or lactation;
- •20. Participation in another clinical study involving a test product or medical device within 28 days (or 5 half-lives of the test product, whichever is longer), prior to first dosing;
- •21. Any medical or surgical condition that may interfere with the patient’s participation in the clinical study, significantly interfere with the interpretation of the results, or put the patient at significant risk, according to the Investigator’s judgment, from study participation; or
- •22. For those in Cohort B, prior participation in Stage 1 of this study.
- •23. Known hypersensitivity to IMB-1018972, mannitol, hypromellose, magnesium stearate and pre-gelatinized corn starch (other ingredients of placebo and active).
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