A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt)

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01905540
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 4
• Actual Duration (Months): 1.5
• Patients Per Site Per Month: 18.5

Study Details

Study Description

Brief Summary

This study will evaluate the relative bioavailability of the new SSP-004184SS capsule formulation compared to the original SSP-004184AQ drug plus excipients formulation.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: SSP-004184AQ; Drug: SSP-004184SS	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Open-label, Randomized, 3-Period, Relative Bioavailability Study Comparing the Pharmacokinetics of SSP-004184AQ (Magnesium Salt) to SSP-004184SS (Disodium Salt) Each Administered as a Single Dose and as Two Doses of SSP-004184 (Free Acid) in Healthy Adult Subjects
• Actual Study Start Date: Aug 5, 2013
• Actual Primary Completion Date: Sep 20, 2013
• Actual Study Completion Date: Sep 20, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SSP-004184AQ (single dose) 40 mg/kg (oral capsule form) given once on Day 1	Drug: SSP-004184AQ; Magnesium salt; Other Names: SPD602
Experimental: SSP-004184SS (single dose) 21.8 mg/kg (oral capsule form) given once on Day 1	Drug: SSP-004184SS; Disodium salt; Other Names: SPD602
Experimental: SSP-004184AQ (2 doses) 40 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1	Drug: SSP-004184AQ; Magnesium salt; Other Names: SPD602
Experimental: SSP-004184SS (2 doses) 21.8 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1	Drug: SSP-004184SS; Disodium salt; Other Names: SPD602

Outcome Measures

Primary Outcome Measures

1. Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose [Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.]

   AUC 0-last is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable 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

2. Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After One Dose [Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.]

   AUCinf is the area under the curve extrapolated to infinity, calculated using the observed value of the last nonzero 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.

3. Maximum Plasma Concentration (Cmax) of SSP-004184 After One Dose [Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.]

   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

Secondary Outcome Measures

1. Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After Two Doses [Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.]

   AUClast is the area under the concentration versus time 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.

2. Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After Two Doses [Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.]

   AUCinf is the area under the plasma concentration versus time curve extrapolated to infinity, calculated using the observed value of the last nonzero 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.

3. Maximum Plasma Concentration (Cmax) of SSP-004184 After Two Doses [Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.]

   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.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Age 18-65 years

• Must be considered "healthy".

• Serum ferritin >20ng/mL, hemoglobin >125g/L and erythrocyte indices within normal range

Exclusion Criteria:

• Subject has a clinically significant history or a disorder detected during the medical interview/physical examination at the Screening Visit or any other medical condition that is capable of altering the absorption, metabolism, or elimination of drugs

• Acute illness, as judged by the investigator, within 2 weeks of Day 1 of Treatment Period 1.

• Known or suspected intolerance or hypersensitivity to the investigational products, closely related compounds, or any of the stated ingredients.

• Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months

• History of alcohol or other substance abuse within the last year.

• A positive screen for alcohol or drugs of abuse at the Screening Visit.

• Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure

89mmHg or <49mmHg.

• Twelve-lead ECG demonstrating QTc >450msec at screening.

• Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches.

• Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.

• A positive HIV antibody screen, HBsAg, or HCV antibody screen.

• Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, gum, patch) within 30 days prior to Day 1 of Treatment Period 1.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology of Miami	Miami	Florida	United States	33014

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: NCT01905540
• Other Study ID Numbers: SPD602-111
• First Posted: Jul 23, 2013
• Last Update Posted: Jul 19, 2021
• Last Verified: Jun 1, 2021

Study Results

Participant Flow

Arm/Group Title	AQ-SS-AQ2	AQ-SS-SS2	SS-AQ-AQ2	SS-AQ-SS2
Arm/Group Description	SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.	SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.	SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.	SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
Period Title: Period 1
STARTED	7	7	7	7
COMPLETED	7	7	7	7
NOT COMPLETED	0	0	0	0
Period Title: Period 1
STARTED	7	7	7	7
COMPLETED	7	7	7	7
NOT COMPLETED	0	0	0	0
Period Title: Period 1
STARTED	7	7	7	7
COMPLETED	6	7	6	6
NOT COMPLETED	1	0	1	1

Baseline Characteristics

Arm/Group Title	AQ-SS-AQ2	AQ-SS-SS2	SS-AQ-AQ2	SS-AQ-SS2	Total
Arm/Group Description	SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.	SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.	SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.	SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.	Total of all reporting groups
Overall Participants	7	7	7	7	28
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	43.7 (12.58)	44.4 (11.53)	41.3 (10.27)	42.7 (13.46)	43 (11.4)
Age, Customized (Count of Participants)
>=65 years	1 14.3%	0 0%	0 0%	0 0%	1 3.6%
Between 18 and 65 years	6 85.7%	7 100%	7 100%	7 100%	27 96.4%
Sex: Female, Male (Count of Participants)
Female	2 28.6%	2 28.6%	1 14.3%	2 28.6%	7 25%
Male	5 71.4%	5 71.4%	6 85.7%	5 71.4%	21 75%
Region of Enrollment (Count of Participants)
UNITED STATES	7 100%	7 100%	7 100%	7 100%	28 100%

Outcome Measures

1. Primary Outcome

Title	Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose
Description	AUC 0-last is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable 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
Time Frame	Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.

Arm/Group Title	SSP-004184AQ (Single Dose)	SSP-004184SS (Single Dose)
Arm/Group Description	40 mg/kg (oral capsule form) given once on Day 1	21.8 mg/kg (oral capsule form) given once on Day 1
Measure Participants	28	28
Mean (Standard Deviation) [ng*h/mL]	261901.9 (71252.3)	164340 (43914)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SSP-004184AQ (Single Dose), SSP-004184SS (Single Dose)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of geometric LS means
	Estimated Value	1.244
	Confidence Interval	(2-Sided) 90%; 1.081 to 1.430
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After One Dose
Description	AUCinf is the area under the curve extrapolated to infinity, calculated using the observed value of the last nonzero 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.
Time Frame	Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.

Arm/Group Title	SSP-004184AQ (Single Dose)	SSP-004184SS (Single Dose)
Arm/Group Description	40 mg/kg (oral capsule form) given once on Day 1	21.8 mg/kg (oral capsule form) given once on Day 1
Measure Participants	26	28
Mean (Standard Deviation) [ng*h/mL]	263911.3 (68979.4)	164614.8 (43858.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SSP-004184AQ (Single Dose), SSP-004184SS (Single Dose)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Geometric LS Means
	Estimated Value	1.233
	Confidence Interval	(2-Sided) 90%; 1.070 to 1.422
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Maximum Plasma Concentration (Cmax) of SSP-004184 After One Dose
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	Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.

Arm/Group Title	SSP-004184AQ (Single Dose)	SSP-004184SS (Single Dose)
Arm/Group Description	40 mg/kg (oral capsule form) given once on Day 1	21.8 mg/kg (oral capsule form) given once on Day 1
Measure Participants	28	28
Mean (Standard Deviation) [ng/mL]	110114.3 (26503)	77068.6 (21198.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SSP-004184AQ (Single Dose), SSP-004184SS (Single Dose)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of geometric LS means
	Estimated Value	1.344
	Confidence Interval	(2-Sided) 90%; 1.135 to 1.592
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After Two Doses
Description	AUClast is the area under the concentration versus time 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.
Time Frame	Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment and for whom the primary pharmacokinetic data were considered sufficient and interpretable.

Arm/Group Title	SSP-004184AQ (2 Doses)	SSP-004184SS (2 Doses)
Arm/Group Description	SSP-004184AQ 40mg/kg morning and evening dose.	SSP-004184SS 21.8mg/kg morning and evening dose
Measure Participants	12	13
Mean (Standard Deviation) [ng*hr/mL]	545957 (186707.3)	294186.8 (78102.1)

5. Secondary Outcome

Title	Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After Two Doses
Description	AUCinf is the area under the plasma concentration versus time curve extrapolated to infinity, calculated using the observed value of the last nonzero 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.
Time Frame	Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.

Arm/Group Title	SSP-004184AQ (2 Doses)	SSP-004184SS (2 Doses)
Arm/Group Description	SSP-004184AQ 40mg/kg morning and evening dose.	SSP-004184SS 21.8mg/kg morning and evening dose
Measure Participants	12	10
Mean (Standard Deviation) [ng*hr/mL]	546114.1 (186698.2)	294758.5 (81194.7)

6. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) of SSP-004184 After Two Doses
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	Periods 1 & 2: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72, 96, and 120 hrs. Period 3: Within 30 min pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 12.5, 13, 13.5, 14, 14.5, 16, 20, 24, 48, 72, 96, and 120 hrs.

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.

Arm/Group Title	SSP-004184AQ (2 Doses)	SSP-004184SS (2 Doses)
Arm/Group Description	SSP-004184AQ 40mg/kg morning and evening dose.	SSP-004184SS 21.8mg/kg morning and evening dose
Measure Participants	12	13
Dose 1	112558.3 (28036.8)	77958.3 (34372.5)
Dose 2	73776.9 (17193.2)	43015.4 (11168.8)

Adverse Events

Adverse Event Reporting Description	The Safety Set was defined as all enrolled subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment (defined as treatment emergent adverse events (TEAEs), physical examination findings, clinical laboratory test results, vital sign measurements, and 12-lead ECG readings).
Arm/Group Title	SSP-004184AQ (Single Dose)		SSP-004184SS (Single Dose)		SSP-004184AQ (2 Doses)		SSP-004184SS (2 Doses)
Arm/Group Description	SSP-004184AQ: 40mg/kg (equivalent to 36.2mg/kg free-acid dose) administered as a single dose in a fasted state in the morning.		SSP-004184SS: 21.8mg/kg (equivalent to 18.1mg/kg free-acid dose) administered as a single dose in a fasted state in the morning.		SP-004184AQ: 40mg/kg (equivalent to 36.2mg/kg free-acid dose) administered in the morning and 40mg/kg administered 12 hours later.		SSP-004184SS: 21.8mg/kg (equivalent to 18.1mg/kg free-acid dose) administered in the morning and 21.8mg/kg administered 12 hours later.
All Cause Mortality
	SSP-004184AQ (Single Dose)		SSP-004184SS (Single Dose)		SSP-004184AQ (2 Doses)		SSP-004184SS (2 Doses)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	SSP-004184AQ (Single Dose)		SSP-004184SS (Single Dose)		SSP-004184AQ (2 Doses)		SSP-004184SS (2 Doses)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)		0/12 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	SSP-004184AQ (Single Dose)		SSP-004184SS (Single Dose)		SSP-004184AQ (2 Doses)		SSP-004184SS (2 Doses)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/28 (42.9%)		11/28 (39.3%)		5/12 (41.7%)		5/13 (38.5%)
Gastrointestinal disorders
Diarrhoea	0/28 (0%)	0	0/28 (0%)	0	1/12 (8.3%)	1	0/13 (0%)	0
General disorders
Asthenia	0/28 (0%)	0	0/28 (0%)	0	1/12 (8.3%)	1	1/13 (7.7%)	1
Influenza like illness	0/28 (0%)	0	0/28 (0%)	0	2/12 (16.7%)	2	0/13 (0%)	0
Nervous system disorders
Headache	1/28 (3.6%)	2	2/28 (7.1%)	2	0/12 (0%)	0	2/13 (15.4%)	2
Renal and urinary disorders
Chromaturia	12/28 (42.9%)	12	9/28 (32.1%)	9	1/12 (8.3%)	1	0/13 (0%)	0
Respiratory, thoracic and mediastinal disorders
Nasal congestion	0/28 (0%)	0	0/28 (0%)	0	0/12 (0%)	0	2/13 (15.4%)	2

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.