Hypertension
Conditions
Interventions
Product Code: SLx-2101
Pharmaceutical Form: Capsule, hard
Current Sponsor code: SLx-2101
Other descriptive name: Phosphodiesterase (PDE-5) inhibitor
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Surface Logix, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged between 18 and 70 years, inclusive. -Female subjects of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy, double oophorectomy or tubal ligation or postmenopausal defined as 12 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL and oestradiol levels 90 mmHg and 140 mmHg and 140 mmHg and =65 years) yes 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 pharmacodynamic evaluations. 2. The subject has a history of orthostatic hypotension, fainting spells or blackouts. 3. The subject is taking nitrates and/or alpha-blockers or medication known to affect BP except those allowed in the protocol, please refer to Section 4.2.4 for permitted and prohibited drugs).. 4. The subject has been a regular user of PDE-5 inhibitors and/or is unable to refrain from using these agents for 5 days before and for the period of their participation in the study. 5. The subject is receiving more than THREE antihypertensive agents. 6. The subject has malignant hypertension, primary hyperaldosteronism or secondary hypertension. 7. Screening liver function tests exceeding 1.5 times the upper limit of the normal range. 8. Active pancreatitis. 9. Abuse of alcohol, defined as a average weekly intake of greater than 21 units for males or 14 units for females (1 unit is equivalent to a half pint of beer or 1 measure of spirits or 1 glass of wine). 10. A history of drug abuse. 11. 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. 12. History or presence of severe peripheral vascular disease, coronary heart disease, heart failure (New York Heart Association type II, III or IV), myocardial infarction or cardiac surgery (in the last 12 months), hypertrophic obstructive cardiomyopathy, aortic or mitral valve stenosis, stroke, PCTA in the last 6 months. 13. Known to be infected with the human immunodeficiency virus or hepatitis B or C. 14. The subject has an abnormal thyroid function test assessed by thyroid stimulating hormone (TSH) levels at Screening. 15. Exposure to a new chemical entity within 3 months prior to the first dosing day. 16. Participation in a trial with any drug within 30 days before the start of the study. 17. The subject has a known significant history of non-compliance with prescribed medication. 18. If participation in the study will result in the volunteer having donated more than 500 mL blood (males) in the previous 6 months. 19. Male subjects attempting to father a child during and up to 3 months after the study Female subjects attempting to become pregnant during and up to 3 months after the study. 20. If in the Investigators opinion, the subject is unsuitable to participate in the study. 21. Inability to understand the protocol requirements, instructions and study-related restrictions; the nature, scope and possible consequences of the study. 22. Unlikely to complete the study; e.g., uncooperative attitude, inability to return for Follow-up Visits. 23. Subject is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the study. 24. Vulnerable individuals (e.g., persons kept in detention).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of SLx-2101 5 mg or 10 mg dosed once daily for 14 days on supine and 2-minute standing peripheral systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate up to 24 h post-dose in patients with hypertension.;Primary end point(s): Placebo-corrected supine peripheral SBP, DBP and heart rate at 1, 2, 4, 6, 8, 12, 16 and 24 h post-dose and 2-minute standing peripheral SBP, DBP and heart rate at 2, 4, 8, 12 and 24 h after SLx-2101 5 mg or 10 mg dosed once daily for 14 days.;Secondary Objective: • To determine the effect of single doses of SLx-2101 5 mg or 10 mg on supine and 2-minute standing peripheral SBP and DBP and heart rate in patients with hypertension. • To explore the effect of SLx-2101 5 mg and 10 mg dosed once daily for 14 days on 24 h ambulatory blood pressure and heart rate in patients with hypertension. • To evaluate the single and repeat dose pharmacokinetic profile of SLx-2101 and its M1 metabolite, SLx-2081, in hypertensive patients. • To determine the safety and tolerability of repeat oral doses of SLx-2101 5 mg or 10 mg for 14 days in patients with hypertension. | — |
Countries
Germany
Outcome results
None listed