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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00989079

Enrollment

Registered

2009-10-02

Start date

2009-10-16

Completion date

2009-12-11

Last updated

2020-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Single Ascending Dose Study in healthy subjects

Brief 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.

Interventions

DRUGErtugliflozin

Ertugliflozin will be administered as an extemporaneously prepared suspension/solution for all doses within the initially planned range.

DRUGPlacebo to Ertugliflozin

Correspondingly placebo doses to ertugliflozin will be administered as suspension/solution

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change from baseline in 24-hour weighted mean glucose	Baseline and 24 hours
Inhibition of glucose reabsorption	Up to 24 hours of each dosing period
Renal clearance (CLr) of Ertugliflozin	Up to 24 hours of each dosing period
Urinary recovery of Ertugliflozin	Up to 24 hours of each dosing period
Urinary glucose excretion over 72 hours	Up to 72 hours of each dosing period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026