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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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Ertugliflozin (PF-04971729, MK-8835) is under development for the treatment of Type 2 Diabetes. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of ertugliflozin.
To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics, of multiple oral doses of ertugliflozin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ertugliflozin 1 mg | Experimental | Ertugliflozin 1 mg, oral, once daily for 14 days |
|
| Ertugliflozin up to 5 mg | Experimental | Ertugliflozin up to 5 mg, oral, once daily for 14 days |
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| Ertugliflozin up to 25 mg | Experimental | Ertugliflozin up to 25 mg, oral, once daily for 14 days |
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| Ertugliflozin up to 100 mg | Experimental | Ertugliflozin up to 100 mg, once daily for 14 days |
|
| Placebo | Placebo Comparator | Placebo to Ertugliflozin once daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ertugliflozin | Drug | Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) | Up to 28 days postdose (Up to 42 days) | |
| Number of Participants Discontinuing Study Drug Due to an AE | Up to 14 days | |
| Area under the plasma concentration-time curve (AUC) over the dosing interval tau (AUCtau) for ertugliflozin | Up to 17 days | |
| Maximum plasma concentration (Cmax) of ertugliflozin | Up to 17 days | |
| Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin | Up to 17 days | |
| Ertugliflozin half life (t1/2) | Up to 17 Days | |
| Apparent clearance (CL/F) after a single dose of ertugliflozin | Up to 17 days | |
| Apparent volume of distribution (Vz/F) | Up to 17 days | |
| Observed Accumulation Ratio of Area Under the Curve for the dosing interval of ertugliflozin (Rac[obs]) | Up to 17 days | |
| Change from baseline in 24-hour weighted mean glucose | Baseline and Day 14 | |
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Inclusion Criteria:
Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
Body Mass Index (BMI) of 26.5 to 35.5 kg/m2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Evidence of glycosuria, as defined by a positive urine dipstick test; Fasting (at least 10 hours) serum triglyceride >300 mg/dL; Fasting (at least 10 hours) LDL-cholesterol >190 mg/dL; Fasting (at least 10 hours) serum 25-OH Vitamin D concentration <20 ng/mL
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32337660 | Result | Fediuk DJ, Nucci G, Dawra VK, Cutler DL, Amin NB, Terra SG, Boyd RA, Krishna R, Sahasrabudhe V. Overview of the Clinical Pharmacology of Ertugliflozin, a Novel Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor. Clin Pharmacokinet. 2020 Aug;59(8):949-965. doi: 10.1007/s40262-020-00875-1. | |
| 33813736 | Derived | Marshall JC, Liang Y, Sahasrabudhe V, Tensfeldt T, Fediuk DJ, Zhou S, Krishna R, Dawra VK, Wood LS, Sweeney K. Meta-Analysis of Noncompartmental Pharmacokinetic Parameters of Ertugliflozin to Evaluate Dose Proportionality and UGT1A9 Polymorphism Effect on Exposure. J Clin Pharmacol. 2021 Sep;61(9):1220-1231. doi: 10.1002/jcph.1866. Epub 2021 Jun 19. |
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| ID | Term |
|---|---|
| C570288 | ertugliflozin |
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|
| Placebo to Ertugliflozin | Drug | Placebo oral dosing solutions/suspensions administered once daily for 14 days immediately after breakfast |
|
| Change from baseline in 24-hour urinary glucose excretion |
| Baseline and Day 14 |
| Change from baseline in 24-hour plasma C-peptide | Baseline and Day 14 |
| Inhibition of glucose reabsorption | Baseline and Day 14 |
| Change from baseline in body weight | Baseline and Day 14 |
| Area under the plasma concentration-time curve over 8 hours (AUC[0-8]) for serum intact parathyroid hormone | Up to 17 days |
| Area under the plasma concentration-time curve over 24 hours (AUC[0-24]) for serum intact parathyroid hormone | Up to 17 days |
| Trough concentration of serum intact parathyroid hormone (Ctrough) | Up to 17 days |