Obesity and diabetes, type 2.
Conditions
Interventions
Product Name: EMP16-01 60/20
Pharmaceutical Form: Capsule
INN or Proposed INN: ACARBOSE
CAS Number: 56180-94-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
I
Sponsors
Empros Pharma AB
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male subjects age = 24years, = 60 years inclusive. 2. BMI 33 – 40 kg/m2 or BMI 30-32 kg/m2 together with waist circumference above 102 cm 3. Acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator. ? 4. Adequate renal function: Creatinine =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study. 2. Any significant medical/surgical procedure or trauma within four weeks of the first administration of IMP, at the discretion of the Investigator. 3. Any planned major surgery within the duration of the study. 4. High blood pressure (Above 155/95 mmHg) 5. No medication with drugs affected by or that affect orlistat and acarbose are allowed 2 weeks before the administration of the IMP 6. Known hypersensitivity to any of the test substances. 7. Gastrointestinal problems / diseases, e.g. inflammatory bowel diseases and Irritable bowel syndrome 8. Cholestasis 9. Previous bariatic surgery 10. Previous gallbladder surgery 11. Previous gastrointestinal surgey that might influence gastrointestinal function significantly.. 12. Chronical malabsorptionsyndrom 13. Vitamin B12 deficiecy or other signs of achlorhydria 14. Clinically significant abnormal laboratory values 15. History of severe allergic, cardiac, or hepatic disease 16. A personal or family history of Medullary Thyroid Carcinoma (MTC) 17. A personal or family history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) 18. Shift work within 3 weeks before visit 2. 19. Excessive intake of alcohol, as judged by the Investigator 20. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse. 21. Positive screen for drugs of abuse at screening or on admission to the unit or. ? 22. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV). 23. Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening. ? 24. Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within three months of the first administration of IMP in this study. Subjects consented and screened but not dosed in previous studies are not excluded. ? 25. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements. 26. Engaged in high volume physical exercise, as defined as regular high intensity physical activity (defined as greater than 70% of the maximal pulse rate for 30 min or more) with a total weekly duration of more than 120 min/week. 27. Bile acid malabsorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the appetite/tolerability score of the test formulation (EMP16-01 90/30) with the reference formulation (Xenical®).;Secondary Objective: To compare the appetite/tolerability score between three different test formulations of EMP16-01 (60/20; 90/30; 120/40). To investigate safety as well as biomarkers for appetite regulation, glucose and lipid absorption and metabolism of three different doses of the test formulation (EMP16-01) and compare with the reference formulation (Xenical®).;Primary end point(s): Appetite/Tolerability score, i.e. ratio between subjective appetite score (sum of appetite questions, measured with questionnaire) and gastrointestinal symptoms score (questionnaire assessing eg. diarrhea, flatulence, oily spotting, gastric distention and estimated frequency and intensity of nausea and pain). Daily scores will be tabulated to form a 14 day composite appetite/tolerability score.;Timepoint(s) of evaluation of this end point: The assessment will be made prior to study start and three times per day, 2h 30 min after dose, during the 14 day study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Appetite/tolerability score. Plasma concentration-time profiles and kinetic assessment of the following biomarkers for appetite regulation, glucose and lipid absorption and metabolism and cardiovascular health: • Appetite/tolerability score (see above) as well as individual appetite questions • Efficacy markers: insulin, c-peptide, glucose, TG, glucagon, GLP-1, GIP and CCK • Safety markers: ALAT, ASAT, ALP, Lactate Dehydrogenase (LD), Creatinine, Thyroid-Stimulating Hormone (TSH), Calcitonin, albumin and CRP • Body weight and body composition • Meal pattern • Plasma pharmacokinetics of orlistat ;Timepoint(s) of evaluation of this end point: The assessment of Appetite/Tolerability score will be made prior to study start and three times per day, 2h 30 min after dose, during the 14 day study period. The remaining assessments will be made on day 1 (visit 2) and day 14 (visit 4). Time points for the assessment will be; Pre-dose, 30 min, 1h, 1h 30 min, 2h, 3h 45 min, 4h 15 min, 4h 30 min, 5h, 5h 30min, 6h. | — |
Countries
Sweden
Contacts
Public ContactJerker Linné
CTC, Clinical Trial Consultants AB
Outcome results
None listed