Pure Global

An Absorption, Distribution, Metabolism, Excretion (ADME) Study of [14C]Subasumstat in Adults With Advanced or Metastatic Solid Tumors - Trial NCT05976334

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.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT05976334
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05976334
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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

Study Focus

Solid Tumors

[14C] Subasumstat

Interventional

drug

Sponsor & Location

Takeda

Budapest,Budapest, Hungary

Timeline & Enrollment

Phase 1

Oct 31, 2023

Apr 30, 2025

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, unspecified
Malignant neoplasm of other connective and soft tissue
Carcinoma in situ, unspecified
Malignant neoplasms
Malignant neoplasm: Parametrium

Data Source

ClinicalTrials.gov

NCT05976334

Non-Device Trial