A randomised, double blind, placebo-controlled, cross-over pilot study to examine the safety, tolerability and pharmacodynamic profile of repeat oral doses of SLx-2101 once daily for up to 14 days in patients with secondary Raynaud’s disease.

• Conditions: Raynaud's Disease; MedDRA version: 8.1Level: LLTClassification code 10037917Term: Raynauds

• Registration Number: EUCTR2007-000397-23-DE
• Lead Sponsor: Surface Logix, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-16
• Last Update Posted: 3 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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, double oophrectomy or tubal ligation or postmenopausal defined as 12 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and E2 level less than or equal to 25 pg/mL or
Females, who are of childbearing potential, must use adequate contraception with double protection prior to and during the trial: double barrier methods (condom, diaphragm, coil or intrauterine device (IUD) in combination with spermicide) or hormonal contraception (oral. depot or implants) in combination with a barrier method.
2. Able to provide written informed consent prior to the performance of any study specific procedures.
3. Body weight within a body mass index range of 17 – 30 kg/m2 (inclusive).
4. History of secondary Raynaud’s disease of at least 1 year since diagnosis.
5. A 12-lead ECG at the pre-study medical, which in the opinion of the Investigator has no abnormalities that will compromise safety in this study.
6. No known positive pre-study urine drugs of abuse screen.
7. Subject able and prepared to withdraw from all vasoactive agents (e.g., calcium channel blockers, nitrates, etc.) at least 1 week before initiating in the study.
8. No known positive pre-study hepatitis B antigen, hepatitis C test and human immunodeficiency virus tests.
9. Secondary Raynaud’s disease due to sclerodermia and / or connective tissue disease.
10. Available to complete all study measurements.

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

1. Past or present 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. Subjects with a hypertension stage 2 (JNC7/NIH, 2004): SBP >=160 mmHg and DBP >=100 mmHg.
3. Subjects with hypotension (systolic blood pressure <95 mmHg and diastolic blood pressure <45 mmHg).
4. Hypersensitivity to the active substance of SLx-2101or to any of the excipients.
5. Moderate and severe hepatic impairment according to Child-Pugh class B and C (documented in the medical record). (Child-Pugh criteria are described in the appendix.)
6. Screening liver function tests exceeding 1.5 times the upper limit of the normal range.
7. Abuse of alcohol, defined as a maximum weekly intake of greater than 21 units or an average daily intake of greater than 3 units for males or an average weekly intake of greater than 14 units or an average intake of greater than 2 units for females (1 unit is equivalent to a half pint of beer or 1 measure of spirits or 1 glass of wine, which is equivalent to 10 mg alcohol).
8. History or presence of gastro-intestinal, hepatic or renal disease (serum creatinine > 2.0 mg/dl) or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
9. History or presence of cardiovascular 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.
10. Recent (last 12 months) history of stroke or myocardial infarction.
11. Intake of any vasoactive agents (e.g., calcium channel blockers, nitrates, etc.) less than 1 week before the start of dosing until the end of the study (follow-up visit).
12. Concomitant treatment with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) or inducers (e.g., bosentan, carbamazepine, phenytoin, phenobarbital, St John’s wort and rifamipicine) less than 1 week before start of dosing until the end of the study.
13. Intake of any selective serotonin-reuptake-inhibitors (SSRI).
14. History or presence of loss of vision in one eye caused by a vascular problem.
15. Pregnant or nursing females.
16. Exposure to a new chemical entity within 3 months prior to the first dosing day.
17. Participation in a trial with any investigational drug within 30 days before the start of the study.
18. If participation in the study will result in the subject having donated more than 500 mL blood (males) or 400 mL blood (females) in the previous 6 months.

Study & Design

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