Obesity Clinical Trial
Official title:
A Randomised, Placebo Controlled First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Y14 in Adult Subjects
Verified date | January 2019 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomised, placebo controlled Phase I study to investigate investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Y14 in adult subjects.
Status | Completed |
Enrollment | 77 |
Est. completion date | December 24, 2018 |
Est. primary completion date | December 24, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Adult males aged 18 to 65 years inclusive with BMI between 25.0 and 38.0 kg/m2 inclusive; 2. (PART B only) Subjects who have normal glucose tolerance, Type 2 diabetes, impaired glucose tolerance or impaired fasting glucose according to WHO 2006 and 2011 criteria; 3. Subjects who are otherwise healthy enough to participate, as determined by pre-study medical history, physical examination and 12-lead ECG; 4. 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; 5. Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening; 6. Subjects who are negative for drugs of abuse and alcohol tests at screening and admissions; 7. Subjects who are non-smokers for at least 3 months preceding screening; 8. Subjects who agree to use medically acceptable methods of contraception for at least 3 months after study drug administration; 9. Subjects who agree not to donate sperm for at least 3 months after study drug administration; 10. Subjects who are able and willing to give written informed consent. Exclusion Criteria: 1. Subjects who do not conform to the above inclusion criteria; 2. 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; 3. Subjects who have a clinically relevant surgical history; 4. Subjects who are currently taking any of the following classes of diabetes medications: thiazolidinediones, dipeptidyl peptidase IV inhibitors ('gliptins'), GLP-1 analogues, and insulin; 5. Subjects who have a history of relevant and severe atopy e.g. asthma, angioedema requiring emergency treatment, severe hayfever requiring regular treatment (i.e. taking antihistamines and/or glucorticoids more regularly than 3 times a week), severe eczema requiring regular treatment (i.e. taking antihistamines and/or glucocorticoids more regularly than 3 times a week); 6. Subjects who have a history of relevant drug hypersensitivity; 7. Subjects who have a history of alcohol abuse or alcohol dependence according to DSMIV criteria within the last 2 years; 8. Subjects who have a history of drug or substance abuse according to DSM-IV criteria within the last 2 years; 9. Subjects who have a history of clinically significant migraine as judged by the Investigator. Subjects can be included if they have not had a migraine for the last 3 years; 10. Subjects with a history of pancreatitis or pancreatic cancer; 11. 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); 12. Subjects who have a significant infection or known inflammatory process on screening; 13. Subjects who have acute gastrointestinal symptoms at the time of screening or admission (e.g. nausea, vomiting, diarrhoea, heartburn); 14. Subjects who have an acute infection such as influenza at the time of screening or admission; 15. Subjects who have used prescription drugs within 2 weeks of first dosing. For Part B, patients are allowed to be treated for their diabetes with monotherapy with a sulphonylurea, metformin, or a SGLT-2 inhibitor, dual therapy with any two of the following drug types: a sulphonylurea, metformin, and/or a SGLT-2 inhibitor; triple therapy with a sulphonylurea, metformin, and a SGLT-2 inhibitor. In addition patients in Part B are allowed to take hypolipidaemic and/or antihypertensive treatments, provided that the doses have not been altered within the 4 weeks prior to entering the study. Other medications may be allowed if the Investigator and Sponsor both agree that they will not affect the outcome of the study or the safety of the subject. 16. 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; 17. Subjects who have donated blood within 3 months prior to screening; Subjects who have donated plasma within the 7 days prior to screening; Subjects who have donated platelets within the 6 weeks prior to screening 18. Subjects who have used any investigational drug in any clinical trial within 3 months of their first admission date; 19. Subjects who have received the last dose of investigational drug greater than 3 months ago but who are on extended follow-up; 20. Subjects who have previously received Y14; 21. Subjects who are vegans, vegetarian or have any dietary restriction (unless agreed as not clinically relevant by the PI and Sponsors); 22. Subjects who cannot communicate reliably with the Investigator; 23. Subjects who are unlikely to co-operate with the requirements of the study; 24. History or evidence of abnormal eating behaviour, as observed through the Dutch Eating Behaviour (DEBQ) and SCOFF questionnaires at screening. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Covance Clinical Research Unit | Leeds |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | Covance, Medical Research Council |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment-Emergent Adverse Events (safety and tolerability) | Count of events | Up to 73 days after dosing | |
Secondary | Maximum observed drug concentrations | (Cmax) | Up to 4 days (72h) after dosing and follow-up | |
Secondary | Time of occurrence of Cmax | (tmax) | Up to 4 days (72h) after dosing and follow-up | |
Secondary | Area under the plasma concentration -time curves | (AUC) | Up to 4 days (72h) after dosing and follow-up | |
Secondary | Apparent terminal rate constant | ?z | Up to 4 days (72h) after dosing and follow-up | |
Secondary | Apparent terminal half-life (t1/2) | t½ | Up to 4 days (72h) after dosing and follow-up | |
Secondary | Visual analogue scale scoring as measures of satiety and nausea | % change from baseline | Up to 4 days (72h) after dosing | |
Secondary | Food intake | Assessed by measurement of weight of food eaten during meals supplied during in-patient phase of study | Up to 4 days (72h) after dosing | |
Secondary | Body weight | (kg) | Up to 73 days after dosing |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |