Trial Outcomes & Findings for A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt) (NCT NCT01905540)
NCT ID: NCT01905540
Last Updated: 2021-07-19
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
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.
Results posted on
2021-07-19
Participant Flow
Participant milestones
| Measure |
AQ-SS-AQ2
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.
|
AQ-SS-SS2
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.
|
SS-AQ-AQ2
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.
|
SS-AQ-SS2
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 1
STARTED
|
7
|
7
|
7
|
7
|
|
Period 1
COMPLETED
|
7
|
7
|
7
|
7
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
7
|
7
|
7
|
7
|
|
Period 2
COMPLETED
|
7
|
7
|
7
|
7
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
7
|
7
|
7
|
7
|
|
Period 3
COMPLETED
|
6
|
7
|
6
|
6
|
|
Period 3
NOT COMPLETED
|
1
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
AQ-SS-AQ2
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.
|
AQ-SS-SS2
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.
|
SS-AQ-AQ2
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.
|
SS-AQ-SS2
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 3
Other
|
1
|
0
|
1
|
1
|
Baseline Characteristics
A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt)
Baseline characteristics by cohort
| Measure |
AQ-SS-AQ2
n=7 Participants
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.
|
AQ-SS-SS2
n=7 Participants
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.
|
SS-AQ-AQ2
n=7 Participants
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.
|
SS-AQ-SS2
n=7 Participants
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
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.7 Years
STANDARD_DEVIATION 12.58 • n=5 Participants
|
44.4 Years
STANDARD_DEVIATION 11.53 • n=7 Participants
|
41.3 Years
STANDARD_DEVIATION 10.27 • n=5 Participants
|
42.7 Years
STANDARD_DEVIATION 13.46 • n=4 Participants
|
43 Years
STANDARD_DEVIATION 11.4 • n=21 Participants
|
|
Age, Customized
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Customized
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Region of Enrollment
UNITED STATES
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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
Outcome measures
| Measure |
SSP-004184AQ (Single Dose)
n=28 Participants
40 mg/kg (oral capsule form) given once on Day 1
|
SSP-004184SS (Single Dose)
n=28 Participants
21.8 mg/kg (oral capsule form) given once on Day 1
|
|---|---|---|
|
Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose
|
261901.9 ng*h/mL
Standard Deviation 71252.3
|
164340 ng*h/mL
Standard Deviation 43914
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
SSP-004184AQ (Single Dose)
n=26 Participants
40 mg/kg (oral capsule form) given once on Day 1
|
SSP-004184SS (Single Dose)
n=28 Participants
21.8 mg/kg (oral capsule form) given once on Day 1
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After One Dose
|
263911.3 ng*h/mL
Standard Deviation 68979.4
|
164614.8 ng*h/mL
Standard Deviation 43858.8
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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-004184AQ (Single Dose)
n=28 Participants
40 mg/kg (oral capsule form) given once on Day 1
|
SSP-004184SS (Single Dose)
n=28 Participants
21.8 mg/kg (oral capsule form) given once on Day 1
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of SSP-004184 After One Dose
|
110114.3 ng/mL
Standard Deviation 26503
|
77068.6 ng/mL
Standard Deviation 21198.9
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
SSP-004184AQ (Single Dose)
n=12 Participants
40 mg/kg (oral capsule form) given once on Day 1
|
SSP-004184SS (Single Dose)
n=13 Participants
21.8 mg/kg (oral capsule form) given once on Day 1
|
|---|---|---|
|
Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After Two Doses
|
545957 ng*hr/mL
Standard Deviation 186707.3
|
294186.8 ng*hr/mL
Standard Deviation 78102.1
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
SSP-004184AQ (Single Dose)
n=12 Participants
40 mg/kg (oral capsule form) given once on Day 1
|
SSP-004184SS (Single Dose)
n=10 Participants
21.8 mg/kg (oral capsule form) given once on Day 1
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After Two Doses
|
546114.1 ng*hr/mL
Standard Deviation 186698.2
|
294758.5 ng*hr/mL
Standard Deviation 81194.7
|
SECONDARY outcome
Timeframe: 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.Population: 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.
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-004184AQ (Single Dose)
n=12 Participants
40 mg/kg (oral capsule form) given once on Day 1
|
SSP-004184SS (Single Dose)
n=13 Participants
21.8 mg/kg (oral capsule form) given once on Day 1
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of SSP-004184 After Two Doses
Dose 1
|
112558.3 ng/mL
Standard Deviation 28036.8
|
77958.3 ng/mL
Standard Deviation 34372.5
|
|
Maximum Plasma Concentration (Cmax) of SSP-004184 After Two Doses
Dose 2
|
73776.9 ng/mL
Standard Deviation 17193.2
|
43015.4 ng/mL
Standard Deviation 11168.8
|
Adverse Events
SSP-004184AQ (Single Dose)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
SSP-004184SS (Single Dose)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
SSP-004184AQ (2 Doses)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SSP-004184SS (2 Doses)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SSP-004184AQ (Single Dose)
n=28 participants at risk
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 (Single Dose)
n=28 participants at risk
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.
|
SSP-004184AQ (2 Doses)
n=12 participants at risk
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 (2 Doses)
n=13 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/28
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).
|
0.00%
0/28
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).
|
8.3%
1/12 • Number of events 1
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).
|
0.00%
0/13
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).
|
|
General disorders
Asthenia
|
0.00%
0/28
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).
|
0.00%
0/28
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).
|
8.3%
1/12 • Number of events 1
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).
|
7.7%
1/13 • Number of events 1
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).
|
|
General disorders
Influenza like illness
|
0.00%
0/28
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).
|
0.00%
0/28
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).
|
16.7%
2/12 • Number of events 2
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).
|
0.00%
0/13
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).
|
|
Nervous system disorders
Headache
|
3.6%
1/28 • Number of events 2
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).
|
7.1%
2/28 • Number of events 2
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).
|
0.00%
0/12
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).
|
15.4%
2/13 • Number of events 2
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).
|
|
Renal and urinary disorders
Chromaturia
|
42.9%
12/28 • Number of events 12
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).
|
32.1%
9/28 • Number of events 9
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).
|
8.3%
1/12 • Number of events 1
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).
|
0.00%
0/13
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).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/28
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).
|
0.00%
0/28
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).
|
0.00%
0/12
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).
|
15.4%
2/13 • Number of events 2
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).
|
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