Assessing the Safety and Ability of SG1002 to Overcome Deficits in Hydrogen Sulfide in Heart Failure Patients

Not Applicable

Completed

Brief Summary: Patients with heart failure are reported to have lower levels of hydrogen sulfide in their blood, even though sulfur is available naturally in the diet. Hydrogen sulfide is a molecule that has been shown to have a number of beneficial effects and thus the low levels may contribute to the disease. This trial is testing whether a medical food product of synthetic sulfur molecules, SG1002, can overcome this deficit in blood levels of hydrogen sulfide.

Detailed Description: Subjects with heart failure have been shown to have a deficit in circulating hydrogen sulfide levels, which, since sulfur is not readily bioavailable and is declining in food substances, cannot be treated adequately by diet alone. This deficit in circulating hydrogen sulfide is thought to lead to increases in oxidative stress and with this, associated problems that can contribute to heart failure. This is a study to evaluate the safety and ability of multiple doses of oral SG1002 in subjects with heart failure to reverse the deficits in circulating hydrogen sulfide. The primary objective is to assess the safety and the ability of multiple doses of twice daily administration of SG1002 compared with placebo to increase circulating levels of hydrogen sulfide. Initially, a dose escalation study will be carried out for 21 days in 4 normal subjects, randomized 3:1 active:placebo. Subjects will receive a 200 mg dose BID for 7 days and in no adverse events, escalate to 400 mg for 7 days then 800 mg for 7 days. Safety parameters will be assessed for each dose, along with pharmacokinetic analysis and markers of oxidative stress and heart failure. Following completion of the normal healthy subjects, 10 heart failure subjects will be randomized 4:1 active:placebo and tested as described above.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
SG1002	SG1002	200 mg capsule of SG1002 (alpha sulfur/sodium sulfate)
Sugar capsule	Placebo	One normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Adverse Events	Following 7 days of treatment at each of three doses	The number of subjects reporting Treatment Emergent Adverse Events at any time during the study period.

Secondary Outcome Measures

Name	Time	Method
Assessing Changes in Peak Hydrogen Sulfide Levels in Heart Failure Subjects Following SG1002 Administration.	24 hours	At the start of each dose, blood samples will be obtained and circulating hydrogen sulfide levels will be assessed over a 24 hour period to determine whether SG1002 can overcome the deficits reported in heart failure patients. Peak hydrogen sulfide levels were measured during the first 4 hours post-administration when maximum concentrations of hydrogen sulfide were reached.