A Multiple Dose Study Of Ertugliflozin (PF-04971729, MK-8835) In Otherwise Healthy Overweight And Obese Volunteers (MK-8835-037)

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-14

Study Completion Date

2010-03-18

Brief Summary

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Ertugliflozin (PF-04971729, MK-8835) is under development for the treatment of Type 2 Diabetes. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of ertugliflozin.

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Detailed Description

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To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics, of multiple oral doses of ertugliflozin.

Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ertugliflozin 1 mg

Ertugliflozin 1 mg, oral, once daily for 14 days

Group Type EXPERIMENTAL

Ertugliflozin

Intervention Type DRUG

Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast

Ertugliflozin up to 5 mg

Ertugliflozin up to 5 mg, oral, once daily for 14 days

Group Type EXPERIMENTAL

Ertugliflozin

Intervention Type DRUG

Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast

Ertugliflozin up to 25 mg

Ertugliflozin up to 25 mg, oral, once daily for 14 days

Group Type EXPERIMENTAL

Ertugliflozin

Intervention Type DRUG

Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast

Ertugliflozin up to 100 mg

Ertugliflozin up to 100 mg, once daily for 14 days

Group Type EXPERIMENTAL

Ertugliflozin

Intervention Type DRUG

Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast

Placebo

Placebo to Ertugliflozin once daily for 14 days

Group Type PLACEBO_COMPARATOR

Placebo to Ertugliflozin

Intervention Type DRUG

Placebo oral dosing solutions/suspensions administered once daily for 14 days immediately after breakfast

Interventions

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Ertugliflozin

Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast

Intervention Type DRUG

Placebo to Ertugliflozin

Placebo oral dosing solutions/suspensions administered once daily for 14 days immediately after breakfast

Intervention Type DRUG

Other Intervention Names

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PF-04971729 MK-8835

Eligibility Criteria

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Inclusion Criteria

Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.

Body Mass Index (BMI) of 26.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs).

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).

Evidence of glycosuria, as defined by a positive urine dipstick test; Fasting (at least 10 hours) serum triglyceride \>300 mg/dL; Fasting (at least 10 hours) LDL-cholesterol \>190 mg/dL; Fasting (at least 10 hours) serum 25-OH Vitamin D concentration \<20 ng/mL

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes