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Radiolabeled SPD602

Phase 1

Healthy | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jun 24, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

Radiolabeled SPD602 · 1 trial · 1 indication

Phase 1 1
NCT01824446AME (Absorption, Metabolism, and Excretion) of Radiolabeled SSP-004184Healthy
COMPLETED6 Analytics
PHASE1COMPLETED
AME (Absorption, Metabolism, and Excretion) of Radiolabeled SSP-004184
Healthy
NCT018244466
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Study Endpoints

Primary Endpoints

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.

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.

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.

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.

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.

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.

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Radiolabeled SPD602EXPERIMENTAL -

Interventions

NameTypeDescription
Radiolabeled SPD602 (FBS0701, SSP-004184)DRUGA single oral dose of 3g of radio-labelled SSP-004184 on Day 1
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Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult male subjects aged between 18 and 65 years inclusive Exclusion Criteria: \-

Countries:United States
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Frequently asked questions about Radiolabeled SPD602

What is Radiolabeled SPD602 used for?

Radiolabeled SPD602 is an investigational small molecule being studied in healthy volunteers. It is a radiolabeled form of the compound SSP-004184, used in a Phase 1 study to assess absorption, metabolism, and excretion (AME). The drug is not approved and remains in clinical development.

Who makes Radiolabeled SPD602?

Radiolabeled SPD602 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this investigational small molecule in the United States.

What phase is Radiolabeled SPD602 in?

Radiolabeled SPD602 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 study is complete, with no active trials currently ongoing.

What clinical trials is Radiolabeled SPD602 in?

Radiolabeled SPD602 was studied in one completed Phase 1 clinical trial, NCT01824446, titled 'AME (Absorption, Metabolism, and Excretion) of Radiolabeled SSP-004184'. This trial enrolled 6 healthy male volunteers in the United States and was not randomized or double-blinded.

Is Radiolabeled SPD602 the same as SSP-004184?

Yes, Radiolabeled SPD602 is a radiolabeled form of SSP-004184. The clinical trial NCT01824446 specifically studied the absorption, metabolism, and excretion of radiolabeled SSP-004184, which is the same compound as Radiolabeled SPD602.