Safety and Pharmacokinetic Study of Y242 in Adult Subjects

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

Obesity causes 600 premature deaths per week in the UK and existing treatments are not effective. When humans eat, the bowels naturally secrete chemicals into the bloodstream which make people feel full and which stop eating. One of these chemicals is known as Peptide YY (PYY). The investigators have previously shown that injections of PYY reduce appetite and food intake in human volunteers. The investigators have now developed a very similar chemical, Y242, as a treatment for obesity. Y242 has been tested in animals and has been shown to be safe, to reduce their appetite, and to last for much longer than PYY itself. This study will test Y242 to ensure that it is well tolerated in humans, and to see how long it lasts in the blood stream after being injected under the skin. It will also look for any effects on appetite.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Imperial College London
• Collaborator: Medical Research Council

Criteria

Inclusion Criteria:

• Adult males aged 18 to 50 years inclusive with BMI between 23.0 and 30.0 kg/m^2 inclusive;

• Subjects who are healthy as determined by pre study medical history, physical examination and 12 lead ECG;

• Subjects whose clinical laboratory test results are either within the normal range or if outside this range the abnormalities are judged to be not clinically relevant and are acceptable to the Investigator;

• Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening;

• Subjects who are negative for drugs of abuse and alcohol tests at screening and admissions;

• Subjects who are non-smokers for at least 3 months preceding screening;

• Subjects who agree to use medically acceptable methods of contraception for at least 3 months after study drug administration;

• Subjects who are able and willing to give written informed consent.

Exclusion Criteria:

• Subjects who do not conform to the above inclusion criteria;

• Subjects who have a clinically relevant history or presence of gastrointestinal (especially associated with vomiting), respiratory, renal, hepatic, haematological, lymphatic, neurological (especially if associated with balance disorders or vomiting e.g. migraine or labyrinthitis), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders;

• Subjects who have a clinically relevant surgical history;

• Subjects who have a clinically relevant family history;

• Subjects who have a history of relevant atopy;

• Subjects who have a history of relevant drug hypersensitivity;

• Subjects who have a history of alcoholism;

• Subjects who have a history of drug abuse;

• Subjects who have a history of migraine;

• Subjects who consume more than 21 units of alcohol a week (unit = 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer);

• Subjects who have a significant infection or known inflammatory process on screening;

• Subjects who have acute gastrointestinal symptoms at the time of screening or admission (e.g. nausea, vomiting, diarrhoea, heartburn);

• Subjects who have an acute infection such as influenza at the time of screening or admission;

• Subjects who have used prescription drugs within 4 weeks of first dosing;

• Subjects who have used over the counter medication excluding routine vitamins and paracetamol but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 7 days of first dosing, unless agreed as not clinically relevant by the Principal Investigator and Sponsor;

• Subjects who have donated blood or blood products within 3 months of Day -2 (admission);

• Subjects who have used any investigational drug in any clinical trial within 3 months of Day -2 (admission);

• Subjects who have received the last dose of investigational drug greater than 3 months ago but who are on extended follow-up;

• Subjects who have previously received Y242;

• Subjects who are vegans or have any dietary restrictions;

• Subjects who cannot communicate reliably with the Investigator;

• Subjects who are unlikely to co-operate with the requirements of the study;

• History or evidence of abnormal eating behaviour, as observed through the Dutch Eating Behaviour (DEBQ) and SCOFF questionnaires at screening.