Trial Outcomes & Findings for AME (Absorption, Metabolism, and Excretion) of Radiolabeled SSP-004184 (NCT NCT01824446)
NCT ID: NCT01824446
Last Updated: 2021-06-24
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
6 participants
Primary outcome timeframe
Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.
Results posted on
2021-06-24
Participant Flow
Participant milestones
| Measure |
[14C]SSP-004184
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AME (Absorption, Metabolism, and Excretion) of Radiolabeled SSP-004184
Baseline characteristics by cohort
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.2 Years
STANDARD_DEVIATION 3.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
UNITED STATES
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: The Pharmacokinetic Analysis Set (PAS) was defined as all subjects in the Safety Analysis Set (SAS) for whom the primary pharmacokinetic data are considered sufficient and interpretable. The SAS consisted of subjects who received at least 1 dose of investigational product and had 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 |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-004184
|
251438.3 ng*hr/ml
Standard Deviation 59522.8
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
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 |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-004184
|
119000.0 ng/ml
Standard Deviation 35014.3
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-004184
|
1.0 hours
Interval 1.0 to 1.5
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
The time it takes for the blood plasma concentration of a substance to halve.
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Plasma Half-Life (T1/2) of Radiolabelled SSP-004184
|
13.039 hours
Standard Deviation 5.061
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
The rate at which a drug is removed from the body.
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Total Body Clearance (CL/F) of Radio-Labelled SSP-004184
|
12.754 L/hr
Standard Deviation 4.251
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
The distribution of a medication between plasma and the rest of the body.
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Volume of Distribution (Vz/F) of Radiolabelled SSP-004184
|
216.534 Liters
Standard Deviation 57.590
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-004184
|
156702.7 ng equivalents*hr/g
Standard Deviation 18867.3
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184
|
57216.7 ng equivalents/ml
Standard Deviation 15434.7
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184
|
1.5 hours
Interval 1.0 to 1.5
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-004184
|
2.863 hours
Standard Deviation 1.687
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
CL/F Whole Blood Total Radioactivity of Radio-Labelled SSP-004184
|
19.396 L/hr
Standard Deviation 2.623
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Vz/F Whole Blood Total Radioactivity of Radiolabelled SSP-004184
|
76.731 Liters
Standard Deviation 39.114
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-004184
|
293626.3 ng equivalents*hr/ml
Standard Deviation 78627.1
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Cmax Plasma Total Radioactivity of Radiolabelled SSP-004184
|
103650.0 ng equivalents/ml
Standard Deviation 29083.6
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Tmax Plasma Total Radioactivity of Radiolabelled SSP-004184
|
1.5 hours
Interval 1.0 to 1.5
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Half-Life Plasma Total Radioactivity of Radiolabelled SSP-004184
|
9.389 hours
Standard Deviation 3.538
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
CL/F Plasma Total Radioactivity of Radio-Labelled SSP-004184
|
11.071 L/hr
Standard Deviation 3.947
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Vz/F Plasma Total Radioactivity of Radiolabelled SSP-004184
|
137.108 Liters
Standard Deviation 23.637
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-004184
|
62.4 percentage of radioactivity
Standard Deviation 14.5
|
PRIMARY outcome
Timeframe: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours.Population: PAS
Outcome measures
| Measure |
[14C]SSP-004184
n=6 Participants
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
|
|---|---|
|
Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-004184
|
29.9 percentage of radioactivity
Standard Deviation 13.2
|
Adverse Events
[14C]SSP-004184
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
[14C]SSP-004184
n=6 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Folliculitis
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Chromaturia
|
100.0%
6/6 • Number of events 6
|
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