Study To Estimate The Relative Bioavailability of Ertugliflozin (PF-04971729, MK-8835) in Healthy Adult Participants (MK-8835-039)

A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-04971729 in Lean To Obese, Otherwise Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01114568

Enrollment

Registered

2010-05-03

Start date

2010-05-31

Completion date

2010-06-30

Last updated

2016-03-17

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

Conditions

Healthy

Keywords

Relative Bioavailability, Pharmacokinetics, Pharmacodynamics

Brief summary

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.

Interventions

DRUGErtugliflozin 10 mg tablet

A single dose of 10 mg ertugliflozin administered as 2x5 mg material sparing formulation tablets.

DRUGErtugliflozin OC Fast

Formulation B) Ertugliflozin 10 mg OC Fast

DRUGErtugliflozin OC Slow

Formulation C) Ertugliflozin 10 mg OC Slow

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and/or female subjects between the ages of 21 and 65 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests). Women must be of non childbearing potential * Body Mass Index (BMI) of 18.5 to 35.4 kg/m2; and a total body weight \>50 kg (110 lbs). * An informed consent document signed and dated by the subject. * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

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 screening). * Any condition possibly affecting drug absorption (eg, gastrectomy). * A positive urine drug screen at Screening or prior to dosing in Period 1. * History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.

Design outcomes

Primary

Measure	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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026