Trial Outcomes & Findings for The Effect of Food on the Bioavailability of a Single Dose of SSP-004184SS in Healthy Adult Subjects (NCT NCT01905553)
NCT ID: NCT01905553
Last Updated: 2021-06-24
Results Overview
AUCinf is the area under the plasma concentration versus time curve from time 0 to infinity. 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
9 participants
Primary outcome timeframe
Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72 hours.
Results posted on
2021-06-24
Participant Flow
Participant milestones
| Measure |
SSP-004184SS Fed First
Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions.
|
SSP-004184SS Fasted First
Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.
|
|---|---|---|
|
Period 1
STARTED
|
5
|
4
|
|
Period 1
COMPLETED
|
5
|
4
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
5
|
4
|
|
Period 2
COMPLETED
|
4
|
4
|
|
Period 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
SSP-004184SS Fed First
Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions.
|
SSP-004184SS Fasted First
Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.
|
|---|---|---|
|
Period 2
Adverse Event
|
1
|
0
|
Baseline Characteristics
The Effect of Food on the Bioavailability of a Single Dose of SSP-004184SS in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
SSP-004184SS Fed First
n=5 Participants
Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions.
|
SSP-004184SS Fasted First
n=4 Participants
Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42 Years
STANDARD_DEVIATION 10.89 • n=5 Participants
|
35 Years
STANDARD_DEVIATION 7.62 • n=7 Participants
|
38.9 Years
STANDARD_DEVIATION 9.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED STATES
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72 hours.Population: Pharmacokinetic Set: All subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable.
AUCinf is the area under the plasma concentration versus time curve from time 0 to infinity. 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-004184SS (Fed)
n=9 Participants
21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
|
SSP-004184SS (Fasted)
n=9 Participants
21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 Under Fasted and Fed Conditions
|
112,236.7 ng*hr/mL
Standard Deviation 28,804.8
|
154,676.6 ng*hr/mL
Standard Deviation 28,185.7
|
PRIMARY outcome
Timeframe: Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72 hours.Population: Pharmacokinetic Set: All subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable.
AUClast is the area under the curve from the time of dosing to the last measurable concentration. 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-004184SS (Fed)
n=9 Participants
21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
|
SSP-004184SS (Fasted)
n=9 Participants
21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of SSP-004184 Under Fed and Fasted Conditions
|
112,066.1 ng*hr/mL
Standard Deviation 28,822.9
|
154,446 ng*hr/mL
Standard Deviation 28,066.5
|
PRIMARY outcome
Timeframe: Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72 hours.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-004184SS (Fed)
n=9 Participants
21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
|
SSP-004184SS (Fasted)
n=9 Participants
21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of SSP-004184 Under Fed and Fasted Conditions
|
32,755.6 ng/mL
Standard Deviation 11,797.4
|
70,733.3 ng/mL
Standard Deviation 9,782.9
|
Adverse Events
SSP-004184SS (Fed)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SSP-004184SS (Fasted)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SSP-004184SS (Fed)
n=9 participants at risk
21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
|
SSP-004184SS (Fasted)
n=9 participants at risk
21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Nervous system disorders
Headache
|
22.2%
2/9 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/9
|
11.1%
1/9 • Number of events 2
|
|
Renal and urinary disorders
Chromaturia
|
22.2%
2/9 • Number of events 2
|
22.2%
2/9 • Number of events 2
|
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