Dyslipidemia/hypertriglyceridemia MedDRA version: 8.1 Level: LLT Classification code 10058110 Term: Dyslipidemia
Conditions
Interventions
Product Name: SLx-4090
Product Code: SLx-4090
Pharmaceutical Form: Capsule, hard
Current Sponsor code: SLx-4090
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
Surface Logix
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged between 18 and 65 years, inclusive. Female subjects must be of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy or postmenopausal defined as 12 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL and estrogen levels 130 mg/dL 7. A 12-lead ECG at the pre-study medical, which in the opinion of the Investigator had no abnormalities that will compromise safety in this study. 8. A negative pre-study urine drugs of abuse screen within 21 days of study start. 9. Negative pre-study hepatitis B antigen, hepatitis C test and human immunodeficiency virus tests. 10. Available to complete all study measurements. 11. Willing and able to comply with a standardized diet. 12. Able to provide written informed consent prior to the performance of any study specific procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Past or present disease (e.g., clinically significant forms of atherosclerotic disease, malignancy, gastrointestinal surgery or disease) that is judged by the Investigator to have the potential to interfere with the study procedures, compromise safety, or affect the pharmacokinetic and pharmacodynamic evaluations. 2. Uncontrolled hypertension with blood pressure higher than 160/95 mmHg or poorly controlled diabetes with HbA1C > 9% at Screening. 3. Active pancreatitis. 4. Presence of overt proteinuria (> 200 mg/L) at Screening. 5. Glomerular filtration rate of = 40 mL/minute at screening (calculated using Cockkroft and Gault's formula). 6. Screening liver function tests alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl-transferase (GGT) exceeding three-times the upper limit of the normal range. 7. Abuse of alcohol, defined as a maximum weekly intake of greater than 140 g or an average daily intake of greater than 20 g (20 g alcohol are contained in 0.5 L of 5° beer or 3 measures of spirits 40° or 0.25 L wine 10°). 8. A history of drug abuse. 9. Any prescribed or over the counter medication taken within 2 weeks prior to the administration of study drug or within 6 times the elimination half life of the medication prior to the study drug intake (whichever is longer). Exceptions will include any concomitant medication that fulfils the criteria described in Section 4.2.4. 10. History or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs. 11. Exposure to any new chemical entities within 12 months prior to the first dosing day. 12. Participation in a trial with any drug within 3 months before the start of the study. 13. Blood donation of more than 500 mL blood in the previous 3 months. 14. Subjects attempting to father a child during and up to 3 months after the study 15. Any confirmed significant allergic reaction against any drug or multiple allergies. 16. Subjects do not report to the unit fasting on the evening of Day -1 and/or do not provide a diary card with sufficient information to derive their average daily food intake.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of repeat oral doses of SLx-4090 200 mg tid and 200 mg od for 14 days on plasma triglycerides in subjects with high triglyceride values.;Secondary Objective: •To investigate the effect of repeat oral doses of SLx-4090 for 14 days on additional pharmacodynamic parameters (high density lipoprotein (HDL), LDL, total cholesterol and ApoB lipoprotein) in subjects with high triglyceride values. • To determine the safety and tolerability of repeat oral doses of SLx-4090 for 14 days in subjects with high triglyceride values. • To investigate the pharmacokinetics of repeat oral doses of SLx-4090 for 14 days in subjects with high triglyceride values. • To determine changes in pharmacodynamic and pharmacokinetic profiles following daily tid and od doses of SLx-4090 and on a day where all administered meals have a high fat content (Day 10). • To investigate the effects of SLx-4090 on the composition, including the fat and lipid composition, of feces following Day 1 (placebo), 2 and 15 daily doses of SLx-4090 in male and female patients with hypertriglyceridemia ;Primary end point(s): Plasma triglyceride concentrations: on Day 1 after placebo dosing, on Day 2 following SLx-4090 (or placebo) and on Day 15, after repeat dosing for 14 days. | — |
Countries
Germany
Outcome results
None listed