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Unlabeled ertugliflozin for use

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Sep 18, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

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Clinical trial landscape

Unlabeled ertugliflozin for use · 1 trial · 1 indication

Phase 1 1
NCT02411929A Phase 1 Study of Ertugliflozin in Healthy Male Participants (MK-8835-020)Type 2 Diabetes Mellitus
COMPLETED8 Analytics
PHASE1COMPLETED
A Phase 1 Study of Ertugliflozin in Healthy Male Participants (MK-8835-020)
Type 2 Diabetes Mellitus
NCT024119298
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Study Endpoints

Primary Endpoints

Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUC Last) (Dose Normalized to 1 mg) and Absolute Oral Bioavailability (F) (Period 1)
Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion

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.

Secondary Endpoints

Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUC Last) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV (Period 1) (Dose Not Normalized to 1 mg)
Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion
Pharmacokinetic Parameter: (AUC Inf) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)
Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion
Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1) (Dose Normalized to 1 mg)
Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ErtugliflozinEXPERIMENTALPeriod 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.

Interventions

NameTypeDescription
Unlabeled ertugliflozin for oral useDRUG15 mg oral (3 x 5 mg tablets)
14^C-labeled ertugliflozin for IV useDRUG100 µg (10 µg/mL solution IV) containing approximately 400 nCi 14\^C (ie, radiolabeled ertugliflozin)
14^C-labeled ertugliflozin for oral useDRUG100 µg (10 µg/mL solution oral) containing approximately 400 nCi 14\^C (ie, radiolabeled ertugliflozin)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersYes

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...

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Frequently asked questions about Unlabeled ertugliflozin for use

What is ertugliflozin used for?

Ertugliflozin is being studied for the treatment of Type 2 Diabetes Mellitus. It is an investigational small molecule in Phase 1 clinical development, and it is not yet approved for any use.

Who makes ertugliflozin?

Ertugliflozin is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics.

What phase is ertugliflozin in?

Ertugliflozin is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials.

What clinical trials is ertugliflozin in?

Ertugliflozin has one completed Phase 1 clinical trial, NCT02411929, titled 'A Phase 1 Study of Ertugliflozin in Healthy Male Participants (MK-8835-020)'. This trial enrolled 8 healthy male participants aged 18 years and older.

Is ertugliflozin the same as MK-8835?

Ertugliflozin is also known as MK-8835, as indicated by the clinical trial title. The trial NCT02411929 is referred to as MK-8835-020, confirming that MK-8835 is an alternative name for ertugliflozin.