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Test Euthyrox

Phase 1

Healthy | Small molecule | Other |Merck KGaA|Last Updated: Nov 25, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

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 Euthyrox used for?

Euthyrox is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its bioequivalence. The drug is being developed by Merck KGaA.

Who makes Euthyrox?

Euthyrox is being developed by Merck KGaA, a company traded under the ticker MKGAF. The drug is currently in Phase 1 clinical development, with one completed trial in healthy volunteers.

What phase is Euthyrox in?

Euthyrox is in Phase 1 clinical development. It has one completed trial with 56 participants, all healthy volunteers. The drug is investigational and has not been approved for any indication.

What clinical trials is Euthyrox in?

Euthyrox has one completed Phase 1 trial, NCT05174000, which studied the bioequivalence of Euthyrox tablets from different manufacturing sites. The trial enrolled 56 healthy volunteers in China and was completed.

Is Euthyrox FDA approved?

Euthyrox is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. One trial, NCT05174000, has been completed in healthy volunteers to assess bioequivalence.