Ischaemic heart disease
Conditions
Interventions
Product Name: DG-031 250 mg
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: DG-031
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Product Name:
Sponsors
deCODE genetics ehf.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The criteria listed below will be assessed at Visit 1 unless stated otherwise. Laboratory measurements to be performed require an overnight fast =8 hours in duration. 1. Age 40 to 75. 2. Carrier of the FLAP and/or the LTA4 hydrolase haplotype (as suggested by results of previous deCODE genetics’ studies). 3. Diagnosis of CAD (based on interview, medication history and physical examination). 4. All women of childbearing potential must have a negative urine pregnancy test at Visit 1. Since the interaction of DG-031 with hormonal contraceptives has not been fully established, it must be considered to potentially decrease their efficacy. Therefore, all women of childbearing potential are required to use 2 adequate barrier methods of contraception throughout the study starting with Visit 1 and for 14 days after the last dose of study medication. Adequate barrier methods of contraception are defined as use of 2 of the following: diaphragm, condom (by the partner), hormonal or copper intrauterine device, or spermicide. Only women agreeable to reliably using double-barrier methods of contraception should be enroled. Note: Women of childbearing potential are defined as premenopausal and have not had surgical sterilisation (hysterectomy or bilateral tubal ligation or bilateral oophorectomy). Postmenopausal status is defined as age 43 years and (1) no menses for >1 year but =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Individuals are excluded from participation in the study if they meet any of the following criteria at Visit 1. 1. Congestive heart failure (CHF). 2. Any experimental treatment within 2 months of screening or planned for the following 3 months. 3. Acute CV event (such as ACS, MI or stroke) within 1 month prior to enrolment. 4. Elevated CPK above 3 fold upper normal limit (UNL). Other liver function tests and kidney function tests above 1.5 fold upper normal limit. 5. Immunocompromised subjects, including subjects known to be HIV positive or with malignant disease and/or on chronic immunosuppressive therapy. 6. Subjects known to have positive serology results for HBsAg, HCV Ab. 7. Treatment with immunosuppressive cytotoxic drugs or corticosteroids within 6 weeks or during conduct of study. 8. Major surgery within 6 weeks prior to enrolment. 9. Any other major intercurrent illness and other condition, which, in the investigator’s judgement, will interfere with the subject’s participation in this study. 10. Subjects not willing to return for follow-up or with known history of non-compliance. 11. Subjects not willing to adhere to restrictions of alcohol use for the duration of the study (=3 units of alcohol/day or =15 units of alcohol/week and no alcohol for 48 hours prior to clinic visits). Note: A unit of alcohol is defined as a single measure of spirit (25 ml), one small glass of sherry or fortified spirit (50 ml), one small glass of wine (125 ml) or one small regular strength beer (330 ml, 4-5%). 12. Pregnant or lactating women. 13. Poor mental function or any other reason to expect difficulty in complying with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To determine the pharmacokinetic parameters of three different doses of the drug DG-031 (375 mg q.d., 375 mg b.i.d. and 250 mg t.i.d.). 2. To assess the pharmacokinetic/pharmacodynamic relationship between DG-031 and LTB4 in blood (serum or plasma) and ionomycin-induced LTB4 release from neutrophils in whole blood.;Secondary Objective: 1. To determine the effect of three different doses of DG-031 on: a) Serum biomarkers: MPO, CRP and amyloid A. b) Ionomycin-induced MPO release from neutrophils in whole blood. c) LTE4 metabolites in urine. 2. To assess the tolerability and safety of DG-031 250 mg t.i.d., 375 mg q.d. and 375 mg b.i.d. in patients with CAD.;Primary end point(s): 1. In the protocol defined study population, there is a pharmacokinetic/pharmacodynamic relationship between LTB4 levels in blood (serum or plasma), LTB4 release from ionomycin-induced neutrophils in whole blood and serum concentrations of DG-031. | — |
Countries
Iceland
Outcome results
None listed