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TD-8954

Phase 1

Enteral Feeding Intolerance | Small molecule | Gastrointestinal |Takeda Pharmaceutical Company Limited|Last Updated: Feb 18, 2020

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

TD-8954 · 1 trial · 1 indication

Phase 1 1
NCT01953081A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding IntoleranceEnteral Feeding Intolerance
COMPLETED13 Analytics
PHASE1COMPLETED
A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance
Enteral Feeding IntoleranceUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse Events
6 Days

the number of subjects reporting adverse events by treatment group

Gastric Retention by Scintigraphy
180 minutes

Number of subjects with retention less than 13% at 180 minutes after dosing.

Secondary Endpoints

Tmax
72 hours
AUC
72 hours
Cmax
72 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TD-8954EXPERIMENTALTD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
MetoclopramideACTIVE_COMPARATORMetoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline

Interventions

NameTypeDescription
TD-8954DRUG -
MetoclopramideDRUG -
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Intubated, on mechanical ventilation, and anticipated to remain on mechanical ventilation for 2 days after enrollment into the study * Receiving enteral feeding and assessed to have developed EFI, as defined by a GRV measurement ≥250 mL within the 24 hours before randomization...

Countries:Australia
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Frequently asked questions about TD-8954

What is TD-8954 used for?

TD-8954 is an investigational small molecule being developed for enteral feeding intolerance, a gastrointestinal condition in critically ill patients who cannot tolerate tube feeding. It is administered intravenously and is currently in Phase 1 clinical development.

How does TD-8954 work?

TD-8954 is a small molecule designed to address enteral feeding intolerance, but its specific molecular target has not been disclosed. It is being studied for its pharmacodynamic effects in critically ill patients, though the exact mechanism of action is not publicly detailed.

Who makes TD-8954?

TD-8954 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company headquartered in Japan. Takeda is listed on the stock exchange under the ticker symbol TAK.

What phase is TD-8954 in?

TD-8954 is in Phase 1 clinical development. It has completed one Phase 1 trial, and it remains an investigational drug that has not been approved by regulatory authorities. Its safety and efficacy are still being evaluated in clinical studies.

What clinical trials is TD-8954 in?

TD-8954 has been studied in one completed Phase 1 clinical trial, identified as NCT01953081. This randomized, double-blind, active-controlled study evaluated a single intravenous dose of TD-8954 compared with metoclopramide in 13 critically ill patients with enteral feeding intolerance in Australia.

Is TD-8954 the same as metoclopramide?

No, TD-8954 is not the same as metoclopramide. Metoclopramide is an existing medication used as an active comparator in the clinical trial of TD-8954, which is an investigational drug being studied for enteral feeding intolerance. They are distinct compounds.