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Human ADME

Phase 1

Undisclosed | Small molecule | Other |Merck & Company, Inc.|Trials Updated: Nov 15, 2019

Human ADME development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2011

Human ADME target and mechanism

Molecular targetINSR
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Human ADME clinical trials

Human ADME · 1 trial · 1 indication

Phase 1 1
NCT01442831Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male SubjectsHealthy
COMPLETED6 Analytics
PHASE1COMPLETED
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

To describe the single dose plasma PK of TR-700, the microbiologically active molecule
pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, then daily up to 312 hours post dose

To describe the single dose pharmacokinetics (Cmax, Tmax, AUC, t 1/2, CL/F) of total radioactivity in plasma, whole blood, urine and feces following oral (PO) administration of \[14C\] TR 701 in healthy adult male subjects

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Human ADMEEXPERIMENTAL -

Interventions

NameTypeDescription
Human ADMEDRUGOral single dose
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Eligibility Criteria

Age Range18 Years to 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Males, between 18 and 50 years of age, inclusive. 2. Body mass index (BMI) of 20 kg/m2 to 29.9 kg/m2, inclusive. 3. In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs. Exclusion...

Countries:United States
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Frequently asked questions about Human ADME

What is Human ADME?

Human ADME is a Phase 1 small molecule developed by Merck & Company, Inc. (MRK). It is an absorption, metabolism, and excretion study drug evaluated in healthy adult male volunteers. The clinical program is focused on understanding how the body processes the compound rather than treating a specific disease.

What does Human ADME target?

Human ADME targets INSR, the insulin receptor, and acts as an agonist at that receptor. The compound is a small molecule designed to interact with INSR. This target class places it among agents that activate insulin receptor signaling.

Who makes Human ADME?

Human ADME is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program for this compound.

What phase is Human ADME in?

Human ADME is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA. The program has completed one Phase 1 trial, and no active trials are currently listed.

What clinical trials is Human ADME in?

Human ADME has been studied in one completed Phase 1 trial, NCT01442831, titled Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects. The trial enrolled 6 healthy adult male participants in the United States and was an uncontrolled study.