Raynaud's Disease MedDRA version: 8.1 Level: LLT Classification code 10037917 Term: Raynauds
Conditions
Interventions
Product Name: SLx-2101
Product Code: SLx-2101
Pharmaceutical Form: Capsule, hard
Current Sponsor code: SLx-2101
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
P
Sponsors
Surface Logix, Inc.
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, 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the severity of secondary Raynaud’s disease-related attacks during the 14-day SLx-2101 dosing period.;Secondary Objective: - To investigate the frequency and total daily duration of secondary Raynaud’s disease-related attacks during the 14-day SLx-2101 dosing period. - To determine the safety and tolerability of repeat oral doses of SLx-2101 in patients with secondary Raynaud’s disease over 14 days dosing. - To explore the effect of SLx-2101 on capillary blood flow velocity and vasospastic symptoms in patients with secondary Raynaud’s disease. - To determine the pharmacokinetic profile of repeat oral doses of SLx 2101 in patients with secondary Raynaud’s disease. - To assess changes in pulmonary artery systolic pressure (PASP) using Doppler echocardiography. - To investigate the effects of SLx-2101 on inflammatory parameters (CRP, IL-6) and on brain natriuretic peptide (BNP). ;Primary end point(s): Daily Raynaud’s condition scores derived from patient questionnaires on scaled ratings (0 points - subject had no difficulties with the Raynaud’s condition; 10 points - subject had extreme difficulties). | — |
Countries
Germany
Outcome results
None listed