Trial Outcomes & Findings for Assessing the Safety and Ability of SG1002 to Overcome Deficits in Hydrogen Sulfide in Heart Failure Patients (NCT NCT01989208)
NCT ID: NCT01989208
Last Updated: 2020-05-05
Results Overview
The number of subjects reporting Treatment Emergent Adverse Events at any time during the study period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Following 7 days of treatment at each of three doses
Results posted on
2020-05-05
Participant Flow
Participant milestones
| Measure |
Sugar Capsule
Two normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period.
|
SG1002
200 mg capsule of SG1002 (alpha sulfur/sodium sulfate)
SG1002: 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 to six normal healthy subjects and six heart failure subjects.
|
|---|---|---|
|
200 mg (7 Days)
STARTED
|
4
|
12
|
|
200 mg (7 Days)
COMPLETED
|
4
|
11
|
|
200 mg (7 Days)
NOT COMPLETED
|
0
|
1
|
|
400 mg (7 Days)
STARTED
|
4
|
11
|
|
400 mg (7 Days)
COMPLETED
|
4
|
11
|
|
400 mg (7 Days)
NOT COMPLETED
|
0
|
0
|
|
800 mg (7 Days)
STARTED
|
4
|
11
|
|
800 mg (7 Days)
COMPLETED
|
4
|
11
|
|
800 mg (7 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sugar Capsule
Two normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period.
|
SG1002
200 mg capsule of SG1002 (alpha sulfur/sodium sulfate)
SG1002: 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 to six normal healthy subjects and six heart failure subjects.
|
|---|---|---|
|
200 mg (7 Days)
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Assessing the Safety and Ability of SG1002 to Overcome Deficits in Hydrogen Sulfide in Heart Failure Patients
Baseline characteristics by cohort
| Measure |
Sugar Capsule
n=4 Participants
Two normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period.
|
SG1002
n=12 Participants
200 mg capsule of SG1002 (alpha sulfur/sodium sulfate)
SG1002: 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.
Six normal healthy subject and six heart failure subjects will be randomized and given SG1002 throughout the trial period.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Normal Healthy Subjects
|
27.0 years
n=5 Participants
|
27.7 years
n=7 Participants
|
27.5 years
n=5 Participants
|
|
Age, Customized
Heart Failure Subjects
|
73.0 years
n=5 Participants
|
75.5 years
n=7 Participants
|
74.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=5 Participants
|
12 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Condition
Normal Healthy Subjects
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Condition
Heart Failure Subjects
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Following 7 days of treatment at each of three dosesThe number of subjects reporting Treatment Emergent Adverse Events at any time during the study period.
Outcome measures
| Measure |
Sugar Capsule
n=4 Participants
Two normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period.
|
SG1002
n=12 Participants
200 mg capsule of SG1002 (alpha sulfur/sodium sulfate)
SG1002: 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.
Six normal healthy subject and six heart failure subjects will be randomized and given SG1002 throughout the trial period.
|
400 mg SG002
400 mg capsules of SG1002 were administered BID for 7 days to heart failure subjects.
|
800 mg SG1002
800 mg capsules of SG1002 were administered BID for 7 days to heart failure subjects.
|
SG1002: Day 0
Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, prior to any drug administration.
|
SG1002: Day 7
Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, following administration of 200 mg SG1002 BID for 7 days.
|
SG1002: Day 14
Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, following administration of 200 mg SG1002 BID for 7 days, then 400 mg SG1002 BID for an additional 7 days.
|
SG1002: Day 21
Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, following administration of 200 mg SG1002 BID for 7 days, then 400 mg SG1002 BID for an additional 7 days and then 800 mg SG1002 BID for an additional 7 days..
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events
Subjects with Treatment Adverse Events
|
2 participants
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Adverse Events
Subjects with no Treatment Emergent Adverse Events
|
2 participants
|
9 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Heart failure subject (n=6) had baseline levels of hydrogen sulfide recorded at 0, 0.5, 1, 2, 4, 6, 12 and 24 hours after the administration of the first dose of each of the escalating doses of SG1002.
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.
Outcome measures
| Measure |
Sugar Capsule
n=6 Participants
Two normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period.
|
SG1002
n=6 Participants
200 mg capsule of SG1002 (alpha sulfur/sodium sulfate)
SG1002: 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.
Six normal healthy subject and six heart failure subjects will be randomized and given SG1002 throughout the trial period.
|
400 mg SG002
n=6 Participants
400 mg capsules of SG1002 were administered BID for 7 days to heart failure subjects.
|
800 mg SG1002
n=6 Participants
800 mg capsules of SG1002 were administered BID for 7 days to heart failure subjects.
|
SG1002: Day 0
Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, prior to any drug administration.
|
SG1002: Day 7
Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, following administration of 200 mg SG1002 BID for 7 days.
|
SG1002: Day 14
Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, following administration of 200 mg SG1002 BID for 7 days, then 400 mg SG1002 BID for an additional 7 days.
|
SG1002: Day 21
Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, following administration of 200 mg SG1002 BID for 7 days, then 400 mg SG1002 BID for an additional 7 days and then 800 mg SG1002 BID for an additional 7 days..
|
|---|---|---|---|---|---|---|---|---|
|
Assessing Changes in Peak Hydrogen Sulfide Levels in Heart Failure Subjects Following SG1002 Administration.
|
0.37 uM
Standard Error 0.05
|
0.44 uM
Standard Error 0.04
|
0.50 uM
Standard Error 0.08
|
0.51 uM
Standard Error 0.09
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 days at each dose.Population: Levels of BNP were recorded at baseline and every 7 days in the placebo group or the SG1002 dose escalation group.
BNP levels were measured for the each subject prior to treatment and after 7 days on each treatment dose, thus representing a change in BNP over the 21 day treatment period. Increased BNP levels are associated with worsening heart failure.
Outcome measures
| Measure |
Sugar Capsule
n=2 Participants
Two normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period.
|
SG1002
n=2 Participants
200 mg capsule of SG1002 (alpha sulfur/sodium sulfate)
SG1002: 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.
Six normal healthy subject and six heart failure subjects will be randomized and given SG1002 throughout the trial period.
|
400 mg SG002
n=2 Participants
400 mg capsules of SG1002 were administered BID for 7 days to heart failure subjects.
|
800 mg SG1002
n=2 Participants
800 mg capsules of SG1002 were administered BID for 7 days to heart failure subjects.
|
SG1002: Day 0
n=6 Participants
Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, prior to any drug administration.
|
SG1002: Day 7
n=6 Participants
Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, following administration of 200 mg SG1002 BID for 7 days.
|
SG1002: Day 14
n=6 Participants
Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, following administration of 200 mg SG1002 BID for 7 days, then 400 mg SG1002 BID for an additional 7 days.
|
SG1002: Day 21
n=6 Participants
Baseline BNP levels of the subjects who were randomized to the SG1002 treatment group, following administration of 200 mg SG1002 BID for 7 days, then 400 mg SG1002 BID for an additional 7 days and then 800 mg SG1002 BID for an additional 7 days..
|
|---|---|---|---|---|---|---|---|---|
|
Assessing Potential Clinical Benefits of SG1002 Administration by Analyzing BNP Levels.
|
85.0 pg/ml
Standard Error 49.0
|
123.0 pg/ml
Standard Error 72.0
|
156.5 pg/ml
Standard Error 97.5
|
149.5 pg/ml
Standard Error 53.5
|
77.5 pg/ml
Standard Error 30.5
|
69.8 pg/ml
Standard Error 26.9
|
79.0 pg/ml
Standard Error 31.6
|
72.0 pg/ml
Standard Error 38.7
|
Adverse Events
Sugar Capsule
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SG1002
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sugar Capsule
n=4 participants at risk
Two normal healthy subject and two heart failure subjects will be randomized and given placebo throughout the trial period.
|
SG1002
n=12 participants at risk
200 mg capsule of SG1002 (alpha sulfur/sodium sulfate)
SG1002: 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.
Six normal healthy subject and six heart failure subjects will be randomized and given placebo throughout the trial period.
|
|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.00%
0/4
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Track Infection
|
25.0%
1/4 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Lethargy/syncope/diahrrea
|
0.00%
0/4
|
8.3%
1/12 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place