Assessing the Safety and Ability of SG1002 to Overcome Deficits in Hydrogen Sulfide in Heart Fail… (NCT01989208) | Clinical Trial Compass
CompletedNot Applicable
Assessing the Safety and Ability of SG1002 to Overcome Deficits in Hydrogen Sulfide in Heart Failure Patients
Australia16 participantsStarted 2014-01
Plain-language 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.
Who can participate
Age range35 Years – 85 Years
SexALL
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Inclusion Criteria (healthy volunteers):
* Healthy male volunteers aged between 18 and 45 years (inclusive);
* Body mass index between 19 and 30 kg/m\^2 (inclusive);
* No clinically significant findings in the medical history and physical examination;
* No clinically significant laboratory values and urinalysis, unless the investigator considers any abnormality to be clinically irrelevant;
* Normal ECG, blood pressure and heart rate, unless the Investigator considers any abnormality to be not clinically significant (NCS);
* Willing to use contraception (single barrier methods); and
* Willing and able to provide written informed consent.
Exclusion Criteria (healthy volunteers):
* Have received blood products within 1 month prior to Screening;
* Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of trial medical food;
* Have received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the trial medical food;
* Have a history of thyroidectomy or thyroid disease that required medication within the past 12 months;
* Have had serious angioedema episodes within the previous 3 years or requiring medication in the previous two years;
* Have a bleeding disorder diagnosed by a doctor (for example factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleedi…
What they're measuring
1
Number of Subjects With Adverse Events
Timeframe: Following 7 days of treatment at each of three doses