ISRCTN12910557已完成1 期
A randomised, placebo-controlled first in human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GLP1-06 in adult subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
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
- 性别
- Male
入选标准
- •1. Male non-smokers aged 18-70 years; body mass index 23 - 45 kg/m²
- •2. Healthy volunteers (Part A)
- •3. For part B only: either healthy volunteers, or those diagnosed with prediabetes or impaired glucose tolerance or impaired fasting glucose or type 2 diabetes but otherwise in good health, as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests; able to communicate with study personnel
- •4. Reliable, willing, and likely to comply with the protocol; willing to comply with the contraception and sperm donation requirements of the protocol.
排除标准
- •1. Not healthy (clinically significant abnormality in our screening tests, which include ECG, vital signs, physical examination, and laboratory safety tests of blood and urine);
- •2. Abuse or have abused alcohol or drugs in the last 2 years;
- •3. Have been treated by a doctor for severe allergic disease (such as severe asthma, or severe hayfever requiring regular treatment)
- •4. Currently taking certain medicines to treat diabetes;
- •5. Taken prescription medicine during the 14 days before dosing; For Part B participants who are stably treated for their diabetes with certain therapy are allowed;
- •6. Taken other medicine (except paracetamol or vitamins), herbal remedies or dietary supplements during the 7 days before first dose;
- •7. Have clinically relevant surgical history;
- •8. Have had a serious reaction to any medicine;
- •9. Have had pancreatitis or pancreatic cancer,
- •10. Have acute gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea, heartburn) at screening or admission
- •11. Have had any condition or operation that might affect the way the body absorbs medicines;
- •12. Have had any clinically significant disease;
- •13. Taken GLP-06 in the past
- •14. Are vegans, or have any significant non-religious dietary restriction which will impact the trial;
- •15. Mental illness might compromise consent;
- •16. Have history or have abnormal eating behaviour as observed through the Dutch Eating Behaviour (DEBQ) and SCOFF questionnaires at screening;
- •17. Unwilling to comply with the contraception requirements of the protocol — because of the potential risk to babies conceived during the study;
- •18. Have donated plasma in the 7 days before screening, or blood in the 3 months before screening, or platelets in the 6 weeks before screening; have taken part in another clinical trial within 3 months before the first admission or are in the follow up period of a clinical trial (where the last dose was taken more than 3 months before);
- •19. Objection by GP on medical grounds — because they might increase the risk, or confound the assessment of GLP-06;
- •20. Have had or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- •21. Have had an episode of hypoglycaemia
- •22. Who have a history of diabetic retinopathy
- •These criteria are designed to select healthy participants, who are robust enough to recover quickly from any adverse effects of GLP-06. We'll study overweight and obese participants because they are the target population for the study medicine.
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