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NCT05976334Not yet recruiting

An Absorption, Distribution, Metabolism, Excretion (ADME) Study of [14C]Subasumstat in Adults With Advanced or Metastatic Solid Tumors

A Phase 1 Study to Assess Mass Balance, Pharmacokinetics, and Metabolism of [14C]Subasumstat in Patients With Advanced or Metastatic Solid Tumors
TakedaPhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Solid Tumors
Drug/Device/Intervention
[14C] Subasumstat
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Takeda
Location
Budapest,Budapest, Hungary
Timeline & enrollment
Phase
Phase 1
Start date
Oct 31, 2023
End date
Apr 30, 2025
Enrollment
10 participants
Primary outcome

Cumulative Percentage of Urinary Recovery,Cumulative Percentage of Fecal Recovery,Cumulative Percentage of Combined Recovery,Percentage Of Recovered Total Radioactivity (TRA) In Urine And Feces

Summary

The main aim of this study is to assess how the human body of adults with advanced or
 metastatic solid tumors absorbs, distributes, metabolizes and excretes subasumstat following
 a single 1 hour infusion of subasumstat.
 
 The study consists of two parts. In Part A, participants will receive a single infusion of
 C14 radiolabeled subasumstat. In Part B, participants will receive subasumstat treatment for
 up to 1 year.

ICD-10 classifications
Malignant neoplasm: Connective and soft tissue, unspecifiedMalignant neoplasm of other connective and soft tissueCarcinoma in situ, unspecifiedMalignant neoplasmsMalignant neoplasm: Parametrium
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05976334
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05976334 through Pure Global AI's free database. This Phase 1 trial is sponsored by Takeda and is currently Not yet recruiting. The study focuses on Solid Tumors. Target enrollment is 10 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.