A Single Escalating Dose Study Of Ertugliflozin (PF-04971729, MK-8835) Under Fed and Fasted Conditons In Healthy Volunteers (MK-8835-036)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 1 Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of PF-04971729 After Administration of Single Escalating Oral Doses Under Fed and Fasted Conditions in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989079
• Other study ID #: 8835-036
• Status: Completed
• Phase: Phase 1
• Start date: October 16, 2009
• Est. completion date: December 11, 2009

Study information

• Verified date: May 2020
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ertugliflozin (PF-04971729, MK-8835) is a new compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this study is to evaluate the safety and tolerability along with the pharmacokinetics of single escalating doses of ertugliflozin under fed and fasted conditions in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 11, 2009
• Est. primary completion date: December 11, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and/or female subjects of non childbearing potential.

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Ertugliflozin
Ertugliflozin will be administered as an extemporaneously prepared suspension/solution for all doses within the initially planned range.
• Placebo to Ertugliflozin
Correspondingly placebo doses to ertugliflozin will be administered as suspension/solution

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Pfizer

References & Publications (1)

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 Apr 27. doi: 10.1007 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing an Adverse Event (AE)		Up to Day 10 of each dosing period
Primary	Number of Participants Discontinuing Study Drug Due to an AE		Up to Day 8 of each dosing period
Primary	Change from baseline in 24-hour urinary glucose excretion		Baseline and 24 hours
Primary	Area under the plasma concentration-time curve (AUC) from Time 0 to infinity (AUCinf) for ertugliflozin		Up to Day 4 of each treatment period
Primary	Area under the plasma concentration-time curve (AUC) from Time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin		Up to Day 4 of each treatment period
Primary	Maximum plasma concentration (Cmax) of ertugliflozin		Up to Day 4 of each treatment period
Primary	Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin		Up to Day 4 of each treatment period
Primary	Ertugliflozin half life (t1/2)		Up to Day 4 of each treatment period
Primary	Apparent clearance (CL/F) after a single dose of ertugliflozin		Up to Day 4 of each treatment period
Primary	Apparent volume of distribution (Vz/F)		Up to Day 4 of each treatment period
Secondary	Urinary glucose excretion over 72 hours		Up to 72 hours of each dosing period
Secondary	Change from baseline in 24-hour weighted mean glucose		Baseline and 24 hours
Secondary	Inhibition of glucose reabsorption		Up to 24 hours of each dosing period
Secondary	Renal clearance (CLr) of Ertugliflozin		Up to 24 hours of each dosing period
Secondary	Urinary recovery of Ertugliflozin		Up to 24 hours of each dosing period