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

NCT01989208 | Completed Results

• 1 other identifier: SG1002-001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Keywords

Heart Failure; Congestive Heart Failure; Oxidative Stress; Hydrogen Sulfide

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Adverse Events

  The number of subjects reporting Treatment Emergent Adverse Events at any time during the study period.

  Following 7 days of treatment at each of three doses

Secondary Outcomes (1)

• Assessing Changes in Peak Hydrogen Sulfide Levels in Heart Failure Subjects Following SG1002 Administration.

  24 hours

Other Outcomes (1)

• Assessing Potential Clinical Benefits of SG1002 Administration by Analyzing BNP Levels.

  7 days at each dose.

Study Arms (2)

Sugar capsule

PLACEBO COMPARATOR

One normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period.

Other: Placebo

SG1002

EXPERIMENTAL

200 mg capsule of SG1002 (alpha sulfur/sodium sulfate)

Other: SG1002

Interventions

SG1002 OTHER

200 mg capsules will be administered BID for 7 days, then doubled to 2 capsules BID for 7 days and doubled again to 4 capsules BID for the final 7 days.

Also known as: alpha sulfur/sodium sulfate

SG1002

Placebo OTHER

200 mg capsules containing placebo will be administered BID for 7 days, then doubled to 2 capsules BID for 7 days and doubled again to 4 capsules BID for the final 7 days.

Sugar capsule

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 bleeding difficulties during blood draws;
• Have a psychiatric condition that precludes compliance with the protocol, past or present psychoses, past or present bipolar disorder, or a disorder requiring lithium, within five years prior to enrolment;
• Has a history of suicide plan;
• Any clinically significant abnormality at Screening determined by medical history, physical examination, blood chemistry, haematology, urinalysis and a 12-lead ECG, or positive urine screen for drugs of abuse;
• Any other condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk;
• HIV, or hepatitis B or C positive;
• Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder;
• Have a history of or current tuberculosis, epilepsy, diabetes or glaucoma;
• Have clinical signs of active infection or a temperature more than 38.0°C at the time of screening. Study entry may be deferred at the discretion of the Principal Investigator;
• Have evidence of drug or alcohol abuse;

Sponsors & Collaborators

• Sulfagenix Australia Pty Ltd.: lead

Study Sites (2)

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• Polhemus DJ, Li Z, Pattillo CB, Gojon G Sr, Gojon G Jr, Giordano T, Krum H. A novel hydrogen sulfide prodrug, SG1002, promotes hydrogen sulfide and nitric oxide bioavailability in heart failure patients. Cardiovasc Ther. 2015 Aug;33(4):216-26. doi: 10.1111/1755-5922.12128.

  PMID: 25930144 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

sodium sulfate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Technical problems in measuring free H2S levels due to sample stability made assessment of PK difficult.

Results Point of Contact

• Title: President and CEO
• Organization: Sulfagenix

tgiordano@sulfagenix.com

1-318-349-3851

Study Officials

• Jason Lickliter, MD, PhD

  Nucleus Network

  PRINCIPAL INVESTIGATOR

• Henry Krum, MBBS, PhD

  The Alfred

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 20, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 5, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-04

Locations

AU (2)