Testing the safety and effects of a new study drug (GCG-06) in adult subjects (GCG-06 - first doses in human)
- Conditions
- ObesityNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN69500549
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 54
1. Male and females of non-childbearing potential non-smokers aged 18-70 years old
2. Body mass index 20-30 kg/m2
3. In good health, as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests
4. Able to communicate with study personnel
5. Reliable, willing, and likely to comply with the protocol
6. Willing to comply with the contraception and gamete donation requirements of the protocol and consent to our informing their GP of their participation in the study, and to our entering their details into the over-volunteering database (TOPS).
1. Unhealthy (clinically significant abnormality in our screening tests, which include ECG, vital signs, physical examination, and laboratory safety tests of blood and urine)
2. Diabetes or prediabetes
3. Abuse or have abused alcohol or drugs in the last 2 years
4. Drink, on average, more than 14 units of alcohol weekly
5. Have been treated by a doctor for severe allergic disease (such as severe asthma, severe hay fever requiring regular treatment, or severe eczema)
6. Currently taking certain medicines to treat diabetes
7. Taken prescription medicine during the 14 days before dosing; taken other medicine (except paracetamol or routine vitamins), herbal remedies or dietary supplements during the 7 days before the first dose; have had a serious reaction to any medicine
8. Have suffered from migraines in the last 3 years
9. Have a clinically relevant surgical history
10. Have had a serious reaction to any medicine
11. History of pancreatitis or pancreatic cancer
12. A history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
13. Have acute gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea, heartburn) at screening or admission
14. Have a current infection (such as flu)
15. Have had any condition or operation that might affect the way the body absorbs medicines
15. Have had any clinically significant disease
16. Taken GCG-06 in the past
17. Have a history or evidence of abnormal eating behaviour
18. Unwilling to comply with the contraception requirements of the protocol — because of the potential risk to babies conceived during the study
19. Have donated plasma in the 7 days before screening, 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); or don't agree to donate blood, or take part in another study, during the 3 months after this study — because participants shouldn't expose themselves to unnecessary medicines more often than a few times a year, nor should they donate too much blood;
20. Objection by GP on medical grounds — because they might increase the risk, or confound the assessment of GCG-06; mental illness might compromise consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method