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SSP-004184AQ

Phase 1

Healthy | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jul 19, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

SSP-004184AQ · 1 trial · 1 indication

Phase 1 1
NCT01905540A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt)Healthy
COMPLETED28 Analytics
PHASE1COMPLETED
A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt)
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

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

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.

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 Endpoints

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.
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.
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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SSP-004184AQ (single dose)EXPERIMENTAL40 mg/kg (oral capsule form) given once on Day 1
SSP-004184SS (single dose)EXPERIMENTAL21.8 mg/kg (oral capsule form) given once on Day 1
SSP-004184AQ (2 doses)EXPERIMENTAL40 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1
SSP-004184SS (2 doses)EXPERIMENTAL21.8 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1

Interventions

NameTypeDescription
SSP-004184AQDRUGMagnesium salt
SSP-004184SSDRUGDisodium salt
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 examina...

Countries:United States
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Frequently asked questions about SSP-004184AQ

What is SSP-004184AQ used for?

SSP-004184AQ is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial assessing its relative bioavailability. The drug is not approved and remains under investigation by its developer.

Who makes SSP-004184AQ?

SSP-004184AQ is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this investigational small molecule, which is currently in Phase 1 development.

What phase is SSP-004184AQ in?

SSP-004184AQ is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved for any use and is still undergoing clinical evaluation.

What clinical trials is SSP-004184AQ in?

SSP-004184AQ has one completed Phase 1 trial, NCT01905540, titled "A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt)." The study enrolled 28 healthy volunteers in the United States and was controlled but not double-blinded.

Is SSP-004184AQ the same as SSP-004184SS?

SSP-004184AQ and SSP-004184SS are related but distinct forms of the same investigational drug. The completed Phase 1 trial compared the relative bioavailability of SSP-004184AQ, a magnesium salt, and SSP-004184SS, a disodium salt, in healthy volunteers.