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Also known as Unlabeled ertugliflozin for oral use
Unlabeled ertugliflozin for use · 1 trial · 1 indication
AUC0-inf is a measure of the mean concentration levels of drug in the plasma after the drug dose. An absolute bioavailability provides information on the amount of a drug reaching the systemic circulation and can be determined by comparing the plasma concentration-time-curves (area under the curve) of a compound after oral application of that compound to that after intravenous application of the same compound.
| Arm | Type | Description |
|---|---|---|
| Ertugliflozin | EXPERIMENTAL | Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C. The 14\^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose. → Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14\^C-labeled ertugliflozin containing approximately 400 nCi 14\^C. Both the unlabeled and 14\^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart). Dosing in Periods 1 and 2 will be separated by a washout of at least 11 days. |
| Name | Type | Description |
|---|---|---|
| Unlabeled ertugliflozin for oral use | DRUG | 15 mg oral (3 x 5 mg tablets) |
| 14^C-labeled ertugliflozin for IV use | DRUG | 100 µg (10 µg/mL solution IV) containing approximately 400 nCi 14\^C (ie, radiolabeled ertugliflozin) |
| 14^C-labeled ertugliflozin for oral use | DRUG | 100 µg (10 µg/mL solution oral) containing approximately 400 nCi 14\^C (ie, radiolabeled ertugliflozin) |
Inclusion Criteria: * Healthy male subjects between the ages of 18 and 65 years. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs.) Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointest...
Unlabeled ertugliflozin for oral use is an investigational small molecule being studied in type 2 diabetes mellitus. It is developed by Merck & Company, Inc. (MRK) and is in Phase 1 clinical development. The oral formulation refers to how the drug is administered in the studies conducted to date.
Unlabeled ertugliflozin for use is an investigational therapy being evaluated for type 2 diabetes mellitus. It is a small molecule developed by Merck & Company, Inc. (MRK). The program is in Phase 1 testing, with one completed clinical trial involving eight healthy male participants.
Unlabeled ertugliflozin for use is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is responsible for the clinical program, including the Phase 1 study conducted in healthy male participants.
Unlabeled ertugliflozin for use is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study enrolled eight healthy male participants and was an uncontrolled, non-randomized, non-double-blind study.
Unlabeled ertugliflozin for use has been studied in one completed Phase 1 trial, NCT02411929, titled A Phase 1 Study of Ertugliflozin in Healthy Male Participants (MK-8835-020). The trial enrolled eight healthy male participants aged 18 years and older and has completed.
Yes, unlabeled ertugliflozin for use is also known as unlabeled ertugliflozin for oral use. Both names refer to the same investigational small molecule developed by Merck & Company, Inc. (MRK) for type 2 diabetes mellitus, currently in Phase 1 development.