An open-label, randomised dose finding study to examine safety, tolerability and dose-related effects of DG-031 on inflammatory biomarkers in serum of patients with history of myocardial infarction (positive or negative for FLAP or LTA4 hydrolase haplotypes) - N/A

Phase 1

• Conditions: Ischaemic heart disease

• Registration Number: EUCTR2005-002145-39-IS
• Lead Sponsor: deCODE genetics ehf.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-18
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1.Age 40 to 75.
2.Serum CRP levels of =2.0.
3.Diagnosis of CAD (based on interview, medication history and physical examination) and history of MI.
4.Postmenopausal women or women of childbearing potential willing to use two adequate barrier methods of contraception or willing to abstain from heterosexual activity throughout the study, starting with Visit 1 and for 14 days after the last dose of study medication. Refer to section 13.5.2 for information on adequate contraceptive methods. All women of childbearing potential must have a negative urine pregnancy test at Visit 1.
Note: Women of childbearing potential are defined as premenopausal, not having had surgical sterilisation (hysterectomy or bilateral tubal ligation or bilateral oophorectomy). Postmenopausal status is defined as =45 years of age with >2 years since last menses.
5.Understanding of the study procedures and agreement to participate in the study by giving written informed consent.

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Congestive heart failure (CHF).
2.Any experimental treatment within 2 months of screening or planned for the following 2 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified