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Test Euthyrox

Phase 2

Undisclosed | Small molecule | Other |Merck KGaA|Trials Updated: Nov 25, 2022

Test Euthyrox development status

Highest phase Phase 2 run by Xeris Pharmaceuticals (NCT05823012)
Phase scored for MKGAFPhase 1
Registered trials 2 across 2 sponsors since Dec 2021

Test Euthyrox target and mechanism

ModalitySmall molecule

Also known as Levothyroxine sodium

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Test Euthyrox clinical trials

Test Euthyrox · 1 trial · 1 indication

Phase 1 1
NCT05174000BE of Euthyrox® Tablets (Merck Nantong Versus Merck Darmstadt Sites)Healthy
COMPLETED56 Analytics
PHASE1COMPLETED
BE of Euthyrox® Tablets (Merck Nantong Versus Merck Darmstadt Sites)
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Serum Concentration, Adjusted for Baseline (Cmax[adj]) of Total Thyroxine (T4)
Pre-dose up to 72 hours post-dose
Baseline-Corrected Area Under the Serum Concentration-Time Curve (AUC) from Time Zero to 72 hours Post-dose (AUC0-72,adj) of Total Thyroxine (T4)
Pre-dose up to 72 hours post-dose

Secondary Endpoints

Serum Concentrations of Total Thyroxine (T4) and Triiodothyronine (T3)
Pre-dose up to 72 hours post-dose
Safety Profile as Assessed by Occurrence of Severity of Treatment-emergent Adverse Events (TEAEs), Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements
Baseline up to 10 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sequence 1:Test Euthyrox®, then Reference Euthyrox®, then Test Euthyrox®, then Reference Euthyrox®EXPERIMENTALParticipants will receive single oral dose of Test Euthyrox® on in treatment period 1, followed by single oral dose of Reference Euthyrox® in treatment period 2, followed by single oral dose of Test Euthyrox® in treatment period 3, followed by single oral dose of Reference Euthyrox in treatment period 4. Participants will remain resident until Day 4 for each treatment period and there will be a washout period of 53 days between each treatment period.
Sequence 2:Reference Euthyrox®, then Test Euthyrox®, then Reference Euthyrox®, then Test Euthyrox®EXPERIMENTALParticipants will receive single oral dose of Reference Euthyrox® in treatment period 1, followed by single oral dose of Test Euthyrox® in treatment period 2, followed by single oral dose of Reference Euthyrox® in treatment period 3, followed by single oral dose of Test Euthyrox® in treatment period 4. Participants will remain resident until Day 4 for each treatment period and there will be a washout period of 53 days between each treatment period.

Interventions

NameTypeDescription
Test Euthyrox®DRUGParticipants will receive single oral dose of Test Euthyrox® either in treatment period 1, 2, 3 or 4.
Reference Euthyrox®DRUGParticipants will receive single oral dose of Reference Euthyrox® either in treatment period 1, 2, 3 or 4.
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Eligibility Criteria

Age Range18 Years to 59 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants have a body weight within 45 to 75 kilogram (kg) for females and 55 to 85 kg for males and Body mass index (BMI) within the range 19.0 to 26.0 kilograms per meter square (kg/m\^2) * Non-smoker for at least 3 months * Contraceptive use by males or females will be c...

Countries:China
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Frequently asked questions about Test Euthyrox

What is Test Euthyrox?

Test Euthyrox is an investigational small molecule developed by Merck KGaA. It has been studied in a Phase 1 clinical trial conducted in China involving 56 healthy adult volunteers. The specific therapeutic indication for Test Euthyrox has not been publicly disclosed.

Who makes Test Euthyrox?

Test Euthyrox is developed by Merck KGaA, which trades under the ticker MKGAF. The company sponsored the clinical evaluation of the drug candidate.

What phase is Test Euthyrox in?

Test Euthyrox is in Phase 1 clinical development. It is an investigational drug candidate and is not approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is Test Euthyrox in?

Test Euthyrox has been evaluated in one completed Phase 1 trial, NCT05174000. The study was titled "BE of Euthyrox® Tablets (Merck Nantong Versus Merck Darmstadt Sites)" and enrolled 56 healthy adult volunteers in China. It was a randomized, controlled trial.

Is Test Euthyrox the same as Test Euthyrox®?

Yes, Test Euthyrox and Test Euthyrox® refer to the same drug candidate. Test Euthyrox® is the registered trademark form of the name used by developer Merck KGaA. Both names identify the same investigational small molecule in Phase 1 development.