Approval Probability
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Adjusted LOA
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Human ADME · 1 trial · 1 indication
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
| Arm | Type | Description |
|---|---|---|
| Human ADME | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Human ADME | DRUG | Oral single dose |
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...
Human ADME is an investigational small molecule being studied in healthy adult male subjects. It is being evaluated in a Phase 1 clinical trial to assess the absorption, metabolism, and excretion of orally administered [14C] TR 701. The drug is not approved and remains in clinical development.
Human ADME is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research on this investigational small molecule in the United States.
Human ADME is in Phase 1 clinical development. The single trial listed for this drug has been completed. It is an investigational drug and has not been approved for any use.
Human ADME has 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 participants in the United States and was not randomized or blinded.
Human ADME is the name of the study drug in the clinical trial, and the trial evaluates [14C] TR 701, which is the radiolabeled form of the drug. The drug is referred to as TR 701 in the trial title, indicating it is the same compound being studied.