Trial Outcomes & Findings for Study of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function (NCT NCT01716455)
NCT ID: NCT01716455
Last Updated: 2021-06-10
Results Overview
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
66 participants
Primary outcome timeframe
Over 96 hours post-dose
Results posted on
2021-06-10
Participant Flow
Participant milestones
| Measure |
SSP-004184 (Mild Renal Impairment)
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Moderate Renal Impairment)
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Severe Renal Impairment)
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (End Stage Renal Disease)
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Matched Healthy Subjects)
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Healthy Elderly Subjects)
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
26
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
26
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function
Baseline characteristics by cohort
| Measure |
SSP-004184 (Mild Renal Impairment)
n=8 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Moderate Renal Impairment)
n=8 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Severe Renal Impairment)
n=8 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (End Stage Renal Disease)
n=8 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Matched Healthy Subjects)
n=26 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Healthy Elderly Subjects)
n=8 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.6 Years
STANDARD_DEVIATION 4.47 • n=99 Participants
|
63.4 Years
STANDARD_DEVIATION 7.56 • n=107 Participants
|
64.4 Years
STANDARD_DEVIATION 8.23 • n=206 Participants
|
44.5 Years
STANDARD_DEVIATION 5.58 • n=7 Participants
|
55.6 Years
STANDARD_DEVIATION 10.81 • n=31 Participants
|
72.6 Years
STANDARD_DEVIATION 5.29 • n=30 Participants
|
58.7 Years
STANDARD_DEVIATION 11.23 • n=3 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
22 Participants
n=3 Participants
|
|
Age, Customized
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
44 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
21 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
45 Participants
n=3 Participants
|
|
Region of Enrollment
UNITED STATES
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
66 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Over 96 hours post-dosePopulation: The Pharmacokinetic Analysis Set is defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data are considered sufficient and interpretable. The Safety Analysis Set consists of all enrolled subjects who take at least 1 dose of investigational product and have at least 1 post dose safety assessment.
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Outcome measures
| Measure |
SSP-004184 (Mild Renal Impairment)
n=8 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Moderate Renal Impairment)
n=8 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Severe Renal Impairment)
n=8 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (End Stage Renal Disease)
n=8 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Matched Healthy Subjects)
n=26 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Healthy Elderly Subjects)
n=8 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184
|
445892.7 ng*hr/ml
Standard Deviation 156768.3
|
932688.3 ng*hr/ml
Standard Deviation 413237.0
|
1531185.8 ng*hr/ml
Standard Deviation 836393.5
|
1261081.6 ng*hr/ml
Standard Deviation 611849.8
|
397400.1 ng*hr/ml
Standard Deviation 126991.1
|
559880.8 ng*hr/ml
Standard Deviation 208295.5
|
PRIMARY outcome
Timeframe: Over 96 hours post-dosePopulation: The Pharmacokinetic Analysis Set is defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data are considered sufficient and interpretable. The Safety Analysis Set consists of all enrolled subjects who take at least 1 dose of investigational product and have at least 1 post dose safety assessment.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Outcome measures
| Measure |
SSP-004184 (Mild Renal Impairment)
n=8 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Moderate Renal Impairment)
n=8 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Severe Renal Impairment)
n=8 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (End Stage Renal Disease)
n=8 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Matched Healthy Subjects)
n=26 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
SSP-004184 (Healthy Elderly Subjects)
n=8 Participants
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of SSP-004184
|
157412.5 ng/ml
Standard Deviation 39231.8
|
168362.5 ng/ml
Standard Deviation 43300.5
|
158250.0 ng/ml
Standard Deviation 34154.1
|
146562.5 ng/ml
Standard Deviation 51181.4
|
136588.5 ng/ml
Standard Deviation 40910.5
|
161525.0 ng/ml
Standard Deviation 53088.4
|
Adverse Events
Impaired Renal Function
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Matched Healthy Subjects
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Healthy Elderly Subjects
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Impaired Renal Function
n=32 participants at risk
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
Matched Healthy Subjects
n=26 participants at risk
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
Healthy Elderly Subjects
n=8 participants at risk
All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
9.4%
3/32 • Number of events 3
|
0.00%
0/26
|
0.00%
0/8
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
2/32 • Number of events 2
|
0.00%
0/26
|
0.00%
0/8
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/32
|
7.7%
2/26 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Urine colour abnormal
|
0.00%
0/32
|
11.5%
3/26 • Number of events 3
|
0.00%
0/8
|
|
Nervous system disorders
Headache
|
3.1%
1/32 • Number of events 1
|
15.4%
4/26 • Number of events 4
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
6.2%
2/32 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
0.00%
0/8
|
|
Renal and urinary disorders
Chromaturia (drug-induced urine coloration)
|
6.2%
2/32 • Number of events 2
|
0.00%
0/26
|
0.00%
0/8
|
|
Cardiac disorders
Tachycardia
|
3.1%
1/32 • Number of events 1
|
0.00%
0/26
|
0.00%
0/8
|
|
General disorders
Chills
|
3.1%
1/32 • Number of events 1
|
0.00%
0/26
|
0.00%
0/8
|
|
General disorders
Fatigue
|
3.1%
1/32 • Number of events 1
|
0.00%
0/26
|
0.00%
0/8
|
|
Infections and infestations
Abscess oral
|
0.00%
0/32
|
3.8%
1/26 • Number of events 1
|
0.00%
0/8
|
|
Investigations
Liver Function Test Abnormal
|
3.1%
1/32 • Number of events 1
|
0.00%
0/26
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.1%
1/32 • Number of events 1
|
0.00%
0/26
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.1%
1/32 • Number of events 1
|
0.00%
0/26
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.1%
1/32 • Number of events 1
|
0.00%
0/26
|
0.00%
0/8
|
|
Nervous system disorders
Dizziness
|
3.1%
1/32 • Number of events 1
|
0.00%
0/26
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER