Type 2 Diabetes
Conditions
Interventions
Product Name: O304
Pharmaceutical Form: Oral suspension
INN or Proposed INN: 4-Chloro-N-(2-(4-chloror-benzyl)-3-oxo-2,3-dihydro-(1,2,4)thiadiazol-5-yl)-benzamide
Current Sponsor code: O304
Concentrati
Sponsors
Betagenon AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study, subjects must fulfil the following criteria: 1. Willing and able to give written informed consent for participation in the study. 2. Male and females aged 18-80 years inclusive. 3. Female subjects must be of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulation hormone 25-140 IE/L and estradiaol =65 years) yes F.1.3.1 Number of subjects for this age range 21
Exclusion criteria
Exclusion criteria: Subjects must not enter the study if any of the following exclusion criteria are fulfilled: 1. History of or presence of (as found at Visit 1) any clinically significant disease, disorder or condition which, in the opinion of the Investigator, may either put the subject at risk due to participation in the study, or influence the results or the subject’s ability to participate in the study. 2. History of Myocardial Infarction (MI), unstable angina, stroke or Transient Ischemic Attack (TIA). 3. Congestive heart failure defined as New York Heart Association (NYHA) class III-IV. 4. Any clinically significant illness, medical or surgical procedure or trauma within four weeks of the first administration of study medication, as judged by the Investigator. 5. Any clinically significant abnormalities in physical examination, ECG or clinical chemistry results at as judged by the Investigator. The following specific exclusion criteria apply to the selected clinical chemistry results: - Creatinine clearance 3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN. - Total bilirubin >2.0 mg/dL (34.2 µmol/L). 6. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV). 7. After 10 minutes of supine rest abnormal vital signs defined as any of the following at the Screening Visit (Visit 1): - Systolic blood pressure > 165 mm Hg - Diastolic blood pressure > 100 mm Hg - Heart rate 85 beats per minute 8. Any condition that is contraindicated with MRI such as, but not limited to, claustrophobia, have a history of brain or heart surgery, any metallic implant (e.g. pacemaker, cochlear implant, hip joint replacement), permanent make-up, work as metalworker or welder or have other MRI contraindications or inability to stay in the supine position for 45 minutes. 9. Any clinically significant incidental finding at the MRI scan performed before randomisation. 10. Known or suspected history of significant drug abuse. 11. History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator. 12. History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to O304. 13. Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening. 14. Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or participation in any other clinical study including drug treatment within three months of the first administration of the IMP in this study. Subjects consented and screened but not dosed in previous phase I studies will not be excluded. 15. Unwilling or unable to adhere to all study visits according to the Clinical Study Protocol (e.g no longer trip than seven days is allowed). 16. Investigator considered subject unlikely to comply with study procedures, restrictions and requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the effect of O304 on FPG levels after 28 days of treatment in subjects with T2D, as compared to placebo.;Secondary Objective: 1. To assess safety and tolerability after 28 days’ treatment in subjects with T2D, as compared to placebo. 2. To assess the exposure of O304 in subjects with T2D and potential relationship to secondary and explorative PD variables.. ;Primary end point(s): The primary endpoint is the mean difference in FPG (mmol/L) after 28 days of treatment.;Timepoint(s) of evaluation of this end point: after 28 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety and tolerability will be assessed by occurrence and frequency of AEs, changes in laboratory parameters, vital signs and physical examination. - The following exposure parameters will be assessed after the last multiple dose: Cmax, Css, Cmin, AUCtau. ;Timepoint(s) of evaluation of this end point: Safety and tolerability will be assessed by occurrence and frequency of AEs, changes in laboratory parameters, vital signs and physical examination will be assessed during the study. PK parameters: Cmin will be assessed at day 7, 14, 21 and 28 | — |
Countries
Sweden
Contacts
Public ContactCEO
Betagenon AB
Outcome results
None listed