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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-16

Study Completion Date

2009-12-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1 Sequence 1

Period 1 (fasted) Placebo → Period 2 (fasted) ertugliflozin (E) 10 mg → Period 3 (fasted) E 100 mg → Period 4 (fed) E 100 mg. Each dose of study drug will be separated by a minimum of 7 days.

Group Type EXPERIMENTAL

Ertugliflozin

Intervention Type DRUG

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

Placebo to Ertugliflozin

Intervention Type DRUG

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

Cohort 1 Sequence 2

Period 1 (fasted) E 0.5 mg → Period 2 (fasted) Placebo → Period 3 (fasted) E 100 mg → Period 4 (fed) E 100 mg. Each dose of study drug will be separated by a minimum of 7 days.

Group Type EXPERIMENTAL

Ertugliflozin

Intervention Type DRUG

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

Placebo to Ertugliflozin

Intervention Type DRUG

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

Cohort 1 Sequence 3

Period 1 (fasted) E 0.5 mg → Period 2 (fasted) E 10 mg → Period 3 (fasted) Placebo → Period 4 (fed) E 100 mg. Each dose of study drug will be separated by a minimum of 7 days.

Group Type EXPERIMENTAL

Ertugliflozin

Intervention Type DRUG

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

Placebo to Ertugliflozin

Intervention Type DRUG

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

Cohort 2 Sequence 1

Period 1 (fasted) Placebo → Period 2 (fasted) E 30 mg → Period 3 (fasted) E 300 mg. Each dose of study drug will be separated by a minimum of 7 days.

Group Type EXPERIMENTAL

Ertugliflozin

Intervention Type DRUG

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

Placebo to Ertugliflozin

Intervention Type DRUG

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

Cohort 2 Sequence 2

Period 1 (fasted) E 2.5 mg → Period 2 (fasted) Placebo → Period 3 (fasted) E 300 mg. Each dose of study drug will be separated by a minimum of 7 days.

Group Type EXPERIMENTAL

Ertugliflozin

Intervention Type DRUG

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

Placebo to Ertugliflozin

Intervention Type DRUG

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

Cohort 2 Sequence 3

Period 1 (fasted) E 2.5 mg → Period 2 (fasted) E 30 mg → Period 3 (fasted) Placebo. Each dose of study drug will be separated by a minimum of 7 days.

Group Type EXPERIMENTAL

Ertugliflozin

Intervention Type DRUG

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

Placebo to Ertugliflozin

Intervention Type DRUG

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

Interventions

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Ertugliflozin

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

Intervention Type DRUG

Placebo to Ertugliflozin

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes