A randomised, double-blind, placebo controlled study to evaluate the pharmacodynamics, safety, tolerability and pharmacokinetics profile of SLx-4090 over 14 days dosing in subjects with high triglyceride values.
- Conditions
- Dyslipidemia/hypertriglyceridemiaMedDRA version: 8.1Level: LLTClassification code 10058110Term: Dyslipidemia
- Registration Number
- EUCTR2007-000536-95-DE
- Lead Sponsor
- Surface Logix
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 < 30 pg/mL or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy.
or
Male partners of female subjects must use a condom/spermicide during sexual intercourse with females of childbearing potential in addition to the subject using a second form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, sub-dermal implants or a tubal ligation if engaging in sexual intercourse. This criterion must be followed from the time of the first dose of study medication until 30 days after the last dose of study medication.
2. Plasma triglyceride concentration of 150 – 900 mg/dL at Screening with a change of no more than 25% from the Screening assessment on Day -4. Subjects who have triglyceride concentrations below the 250 mg/dL or above the 900 mg/dL thresholds on Day -4, but whose levels have changed not more than 10% from Screening, may be included at the Investigators discretion.
3. Void
4. Body weight within a body mass index range of 19 – 35 kg/m2, inclusive.
5. Total cholesterol of more than 200 mg/dL.
6. Low density lipoprotein cholesterol (LDL-C) of > 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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method