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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to examine the rate and extent of absorption of three oral formulations of ertugliflozin (PF 04971729, MK-8835) administered in lean to obese healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ertugliflozin 10 mg: tablet→osmotic capsule (OC) fast→OC slow | Experimental | The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg extemporaneously prepared osmotic capsule with target release rate of approximately 6 hours (EP-Osmotic Capsule-Fast) and C) a single dose of 10 mg extemporaneously prepared osmotic capsule with target release rate of approximately 14 hours (EP-Osmotic Capsule-Slow). Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C. |
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| Ertugliflozin 10 mg: tablet→OC slow→OC fast | Experimental | The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C. |
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| Ertugliflozin 10 mg: OC fast→tablet→OC slow | Experimental | The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ertugliflozin 10 mg tablet | Drug | A single dose of 10 mg ertugliflozin administered as 2x5 mg material sparing formulation tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin | Up to 48 hr. postdose (Up to Day 3 in each dosing period) | |
| AUC from Hour 0 to infinity (AUCinf) for ertugliflozin | Up to 48 hr. postdose (Up to Day 3 in each dosing period) | |
| Maximum plasma concentration (Cmax) of ertugliflozin | Up to 48 hr. postdose (Up to Day 3 in each dosing period) | |
| Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin | Up to 48 hr. postdose (Up to Day 3 in each dosing period) | |
| Ertugliflozin half life (t1/2) | Up to 48 hr. postdose (Up to Day 3 in each dosing period) | |
| Number of Participants Experiencing an Adverse Event (AE) | Up to 28 days postdose (Up to 49 days) | |
| Number of Participants Discontinuing Study Drug Due to an AE | Up to Day 21 | |
| Urinary glucose excretion | Up to 48 hr. postdose (Up to Day 3 in each dosing period) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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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| Ertugliflozin 10 mg: OC fast→OC slow→tablet | Experimental | The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C. |
|
| Ertugliflozin 10 mg: OC slow→tablet→OC fast | Experimental | The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C. |
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| Ertugliflozin 10 mg: OC slow→OC fast→tablet | Experimental | The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C. |
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| Ertugliflozin OC Fast | Drug | Formulation B) Ertugliflozin 10 mg OC Fast |
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| Ertugliflozin OC Slow | Drug | Formulation C) Ertugliflozin 10 mg OC Slow |
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| ID | Term |
|---|---|
| C570288 | ertugliflozin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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