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Sulfatinib T

Phase 1

Undisclosed | Small molecule | Other |HUTCHMED (China) Limited|Trials Updated: Nov 13, 2018

Sulfatinib T target and mechanism

Target class-Tinib (Kinase)
ModalitySmall molecule

Also known as Sulfatinib T capsule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Sulfatinib T clinical trials

Sulfatinib T · 1 trial · 1 indication

Phase 1 1
NCT03483259To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different ManufacturersRelative Bioavailability
COMPLETED30 Analytics
PHASE1COMPLETED
To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers
Relative BioavailabilityUnlock trial analytics

Study Endpoints

Primary Endpoints

The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of Sulfatinib
Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.

Maximum observed plasma concentration (Cmax) of Sulfatinib
Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

Maximum observed concentration, occurring at Tmax.

The time to Cmax (peak time, Tmax) of Sulfatinib
Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

The time at which maximum plasma concentration (Cmax) is observed.

Half-life (t1/2) of Sulfatinib
Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

The time required for the concentration of the drug to reach half of its original value.

Relative Bioavailability
Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5

This term represents the relationship between the bioavailability of a substance in two different media.

Secondary Endpoints

Adverse Event (AE) monitoring of Sulfatinib
Measured from the date signed ICF to within 14 days after the last dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A-Sulfatinib T capsuleEXPERIMENTALThe subjects in this arm will receive sulfatinib T capsules from Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd.
Arm B-Sulfatinib R capsuleEXPERIMENTALThe subjects in this arm will receive sulfatinib R capsules from Beijing Yiling Bioengineering Technology Co., Ltd.

Interventions

NameTypeDescription
Sulfatinib T capsuleDRUGSulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production.
Sulfatinib R capsuleDRUGSulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd.
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Eligibility Criteria

Age Range18 Years to 40 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Subjects must be voluntary and sign an informed consent form and agree to comply with the requirements of the protocol; 2. Age of 18-40 (inclusive), male healthy volunteers; 3. Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as norm...

Countries:China
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Frequently asked questions about Sulfatinib T

What is Sulfatinib T?

Sulfatinib T is an investigational small molecule drug developed by HUTCHMED (China) Limited. It is a kinase inhibitor belonging to the -tinib class. It has been studied in a Phase 1 clinical trial in China. Sulfatinib T is also known as Sulfatinib T capsule.

What does Sulfatinib T target?

Sulfatinib T is a kinase inhibitor, meaning it targets kinases, which are enzymes that regulate cell signaling. As a small molecule in the -tinib class, it is designed to inhibit kinase activity. The specific kinase targets have not been disclosed.

Who makes Sulfatinib T?

Sulfatinib T is developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the Nasdaq under the ticker HCM. HUTCHMED is responsible for the research and clinical development of Sulfatinib T.

What phase is Sulfatinib T in?

Sulfatinib T is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any regulatory agency. The Phase 1 trial has been completed.

What clinical trials is Sulfatinib T in?

Sulfatinib T has been evaluated in one completed Phase 1 clinical trial, NCT03483259, titled "To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers." The trial enrolled 30 male participants in China and was controlled but not double-blind.

Is Sulfatinib T the same as Sulfatinib T capsule?

Yes, Sulfatinib T capsule is an alternative name for Sulfatinib T. Both refer to the same investigational drug developed by HUTCHMED (China) Limited.