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AME (Absorption, Metabolism, and Excretion) of Radiolabeled SSP-004184

A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]SSP-004184 Following a Single Oral Dose in Healthy Male Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01824446
Enrollment
6
Registered
2013-04-04
Start date
2013-05-01
Completion date
2013-05-29
Last updated
2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

To evaluate how the body absorbs, metabolizes (breaks down) and excretes (eliminates) the study drug. Further, the study will determine how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it when given as a single dose to healthy male subjects.

Interventions

DRUGRadiolabeled SPD602 (FBS0701, SSP-004184)

A single oral dose of 3g of radio-labelled SSP-004184 on Day 1

Sponsors

Shire
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy adult male subjects aged between 18 and 65 years inclusive

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-004184Within 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.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.
Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-004184Within 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.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.
Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-004184Within 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.Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
Plasma Half-Life (T1/2) of Radiolabelled SSP-004184Within 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.The time it takes for the blood plasma concentration of a substance to halve.
Total Body Clearance (CL/F) of Radio-Labelled SSP-004184Within 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.The rate at which a drug is removed from the body.
Volume of Distribution (Vz/F) of Radiolabelled SSP-004184Within 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.The distribution of a medication between plasma and the rest of the body.
AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-004184Within 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.—
Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184Within 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.—
Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184Within 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.—
Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-004184Within 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.—
CL/F Whole Blood Total Radioactivity of Radio-Labelled SSP-004184Within 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.—
Vz/F Whole Blood Total Radioactivity of Radiolabelled SSP-004184Within 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.—
AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-004184Within 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.—
Cmax Plasma Total Radioactivity of Radiolabelled SSP-004184Within 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.—
Tmax Plasma Total Radioactivity of Radiolabelled SSP-004184Within 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.—
Half-Life Plasma Total Radioactivity of Radiolabelled SSP-004184Within 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.—
CL/F Plasma Total Radioactivity of Radio-Labelled SSP-004184Within 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.—
Vz/F Plasma Total Radioactivity of Radiolabelled SSP-004184Within 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.—
Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-004184Within 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.—
Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-004184Within 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.—

Countries

United States

Participant flow

Participants by arm

ArmCount
[14C]SSP-004184
A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
6
Total6

Baseline characteristics

Characteristic[14C]SSP-004184
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
Age, Continuous29.2 Years
STANDARD_DEVIATION 3.76
Region of Enrollment
UNITED STATES
6 Participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
6 / 6
serious
Total, serious adverse events
0 / 6

Outcome results

Primary

Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-004184

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-004184251438.3 ng*hr/mlStandard Deviation 59522.8
Primary

AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-004184

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-004184293626.3 ng equivalents*hr/mlStandard Deviation 78627.1
Primary

AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-004184

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-004184156702.7 ng equivalents*hr/gStandard Deviation 18867.3
Primary

CL/F Plasma Total Radioactivity of Radio-Labelled SSP-004184

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184CL/F Plasma Total Radioactivity of Radio-Labelled SSP-00418411.071 L/hrStandard Deviation 3.947
Primary

CL/F Whole Blood Total Radioactivity of Radio-Labelled SSP-004184

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184CL/F Whole Blood Total Radioactivity of Radio-Labelled SSP-00418419.396 L/hrStandard Deviation 2.623
Primary

Cmax Plasma Total Radioactivity of Radiolabelled SSP-004184

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184Cmax Plasma Total Radioactivity of Radiolabelled SSP-004184103650.0 ng equivalents/mlStandard Deviation 29083.6
Primary

Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-00418457216.7 ng equivalents/mlStandard Deviation 15434.7
Primary

Half-Life Plasma Total Radioactivity of Radiolabelled SSP-004184

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184Half-Life Plasma Total Radioactivity of Radiolabelled SSP-0041849.389 hoursStandard Deviation 3.538
Primary

Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-004184

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-0041842.863 hoursStandard Deviation 1.687
Primary

Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-004184

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.

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-004184119000.0 ng/mlStandard Deviation 35014.3
Primary

Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-004184

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-00418429.9 percentage of radioactivityStandard Deviation 13.2
Primary

Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-004184

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-00418462.4 percentage of radioactivityStandard Deviation 14.5
Primary

Plasma Half-Life (T1/2) of Radiolabelled SSP-004184

The time it takes for the blood plasma concentration of a substance to halve.

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184Plasma Half-Life (T1/2) of Radiolabelled SSP-00418413.039 hoursStandard Deviation 5.061
Primary

Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-004184

Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.

Time frame: 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

ArmMeasureValue (MEDIAN)
[14C]SSP-004184Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-0041841.0 hours
Primary

Tmax Plasma Total Radioactivity of Radiolabelled SSP-004184

Time frame: 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

ArmMeasureValue (MEDIAN)
[14C]SSP-004184Tmax Plasma Total Radioactivity of Radiolabelled SSP-0041841.5 hours
Primary

Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184

Time frame: 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

ArmMeasureValue (MEDIAN)
[14C]SSP-004184Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-0041841.5 hours
Primary

Total Body Clearance (CL/F) of Radio-Labelled SSP-004184

The rate at which a drug is removed from the body.

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184Total Body Clearance (CL/F) of Radio-Labelled SSP-00418412.754 L/hrStandard Deviation 4.251
Primary

Volume of Distribution (Vz/F) of Radiolabelled SSP-004184

The distribution of a medication between plasma and the rest of the body.

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184Volume of Distribution (Vz/F) of Radiolabelled SSP-004184216.534 LitersStandard Deviation 57.59
Primary

Vz/F Plasma Total Radioactivity of Radiolabelled SSP-004184

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184Vz/F Plasma Total Radioactivity of Radiolabelled SSP-004184137.108 LitersStandard Deviation 23.637
Primary

Vz/F Whole Blood Total Radioactivity of Radiolabelled SSP-004184

Time frame: 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

ArmMeasureValue (MEAN)Dispersion
[14C]SSP-004184Vz/F Whole Blood Total Radioactivity of Radiolabelled SSP-00418476.731 LitersStandard Deviation 39.114

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026