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

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01824446
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Days): 28
• Patients Per Site Per Month: 6.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Radiolabeled SPD602 (FBS0701, SSP-004184)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]SSP-004184 Following a Single Oral Dose in Healthy Male Subjects
• Actual Study Start Date: May 1, 2013
• Actual Primary Completion Date: May 29, 2013
• Actual Study Completion Date: May 29, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radiolabeled SPD602	Drug: Radiolabeled SPD602 (FBS0701, SSP-004184); A single oral dose of 3g of radio-labelled SSP-004184 on Day 1; Other Names: SPD602

Outcome Measures

Primary Outcome Measures

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

   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.

2. Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-004184 [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.]

   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.

3. Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-004184 [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.]

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

4. Plasma Half-Life (T1/2) of Radiolabelled SSP-004184 [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.]

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

5. Total Body Clearance (CL/F) of Radio-Labelled SSP-004184 [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.]

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

6. Volume of Distribution (Vz/F) of Radiolabelled SSP-004184 [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.]

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

7. AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-004184 [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.]

8. Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184 [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.]

9. Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184 [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.]

10. Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-004184 [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.]

11. CL/F Whole Blood Total Radioactivity of Radio-Labelled SSP-004184 [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.]

12. Vz/F Whole Blood Total Radioactivity of Radiolabelled SSP-004184 [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.]

13. AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-004184 [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.]

14. Cmax Plasma Total Radioactivity of Radiolabelled SSP-004184 [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.]

15. Tmax Plasma Total Radioactivity of Radiolabelled SSP-004184 [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.]

16. Half-Life Plasma Total Radioactivity of Radiolabelled SSP-004184 [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.]

17. CL/F Plasma Total Radioactivity of Radio-Labelled SSP-004184 [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.]

18. Vz/F Plasma Total Radioactivity of Radiolabelled SSP-004184 [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.]

19. Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-004184 [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.]

20. Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-004184 [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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Unit Inc	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT01824446
• Other Study ID Numbers: SPD602-109
• First Posted: Apr 4, 2013
• Last Update Posted: Jun 24, 2021
• Last Verified: Jun 1, 2021

Study Results

Participant Flow

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Period Title: Overall Study
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 100%
>=65 years	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	29.2 (3.76)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	6 100%
Region of Enrollment (Count of Participants)
UNITED STATES	6 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [ng*hr/ml]	251438.3 (59522.8)

2. Primary Outcome

Title	Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-004184
Description	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.

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [ng/ml]	119000.0 (35014.3)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Median (Full Range) [hours]	1.0

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [hours]	13.039 (5.061)

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [L/hr]	12.754 (4.251)

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [Liters]	216.534 (57.590)

7. Primary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [ng equivalents*hr/g]	156702.7 (18867.3)

8. Primary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [ng equivalents/ml]	57216.7 (15434.7)

9. Primary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Median (Full Range) [hours]	1.5

10. Primary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [hours]	2.863 (1.687)

11. Primary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [L/hr]	19.396 (2.623)

12. Primary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [Liters]	76.731 (39.114)

13. Primary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [ng equivalents*hr/ml]	293626.3 (78627.1)

14. Primary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [ng equivalents/ml]	103650.0 (29083.6)

15. Primary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Median (Full Range) [hours]	1.5

16. Primary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [hours]	9.389 (3.538)

17. Primary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [L/hr]	11.071 (3.947)

18. Primary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [Liters]	137.108 (23.637)

19. Primary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [percentage of radioactivity]	62.4 (14.5)

20. Primary Outcome

Title	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.

Outcome Measure Data

Analysis Population Description

PAS

Arm/Group Title	[14C]SSP-004184
Arm/Group Description	A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
Measure Participants	6
Mean (Standard Deviation) [percentage of radioactivity]	29.9 (13.2)

Adverse Events

Arm/Group Title	[14C]SSP-004184
Arm/Group Description
All Cause Mortality
	[14C]SSP-004184
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	[14C]SSP-004184
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	[14C]SSP-004184
	Affected / at Risk (%)	# Events
Total	6/6 (100%)
Gastrointestinal disorders
Diarrhoea	1/6 (16.7%)	1
Infections and infestations
Folliculitis	1/6 (16.7%)	1
Renal and urinary disorders
Chromaturia	6/6 (100%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.