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Radiolabeled SPD557

Phase 1

Healthy Volunteers | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jun 10, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01786876Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in VolunteersPHASE1 COMPLETED 6 — — Mar 7, 2013Apr 12, 2013Jun 10, 20211 United States
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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-002358
Over 240 hours post-dose

Area under the plasma concentration versus time curve from time 0 to infinity. 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-002358
Over 240 hours post-dose

Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.

Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358
Over 240 hours post-dose
Plasma Half-Life (T1/2) of Radiolabelled SSP-002358
Over 240 hours post-dose
AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Over 240 hours post-dose
Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Over 240 hours post-dose
Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Over 240 hours post-dose
Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358
Over 240 hours post-dose
AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358
Over 240 hours post-dose
Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358
Over 240 hours post-dose
Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358
Over 240 hours post-dose
Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358
Over 240 hours post-dose
Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358
Over 240 hours post-dose
Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358
Over 240 hours post-dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Radiolabeled SPD557EXPERIMENTAL -
Interventions
NameTypeDescription
Radiolabeled SPD557DRUGA single oral dose of 2 mg radiolabeled SPD557 administered on Day 1
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Males ages 18 to 50 years * Have a body mass index (BMI) of ≥18.5 and ≤30 kg/m2 * Subject is willing to comply with any applicable contraceptive and sperm donation requirements Key Exclusion criteria: * Have participated in a \[14C\]-study within the last 6 months. * Exp...

Countries:United States
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