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

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Ertugliflozin 10 mg: tablet→osmotic capsule (OC) fast→OC slow

The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg extemporaneously prepared osmotic capsule with target release rate of approximately 6 hours (EP-Osmotic Capsule-Fast) and C) a single dose of 10 mg extemporaneously prepared osmotic capsule with target release rate of approximately 14 hours (EP-Osmotic Capsule-Slow). Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.

Group Type EXPERIMENTAL

Ertugliflozin 10 mg tablet

Intervention Type DRUG

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

Ertugliflozin OC Fast

Intervention Type DRUG

Formulation B) Ertugliflozin 10 mg OC Fast

Ertugliflozin OC Slow

Intervention Type DRUG

Formulation C) Ertugliflozin 10 mg OC Slow

Ertugliflozin 10 mg: tablet→OC slow→OC fast

The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.

Group Type EXPERIMENTAL

Ertugliflozin 10 mg tablet

Intervention Type DRUG

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

Ertugliflozin OC Fast

Intervention Type DRUG

Formulation B) Ertugliflozin 10 mg OC Fast

Ertugliflozin OC Slow

Intervention Type DRUG

Formulation C) Ertugliflozin 10 mg OC Slow

Ertugliflozin 10 mg: OC fast→tablet→OC slow

The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.

Group Type EXPERIMENTAL

Ertugliflozin 10 mg tablet

Intervention Type DRUG

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

Ertugliflozin OC Fast

Intervention Type DRUG

Formulation B) Ertugliflozin 10 mg OC Fast

Ertugliflozin OC Slow

Intervention Type DRUG

Formulation C) Ertugliflozin 10 mg OC Slow

Ertugliflozin 10 mg: OC fast→OC slow→tablet

The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.

Group Type EXPERIMENTAL

Ertugliflozin 10 mg tablet

Intervention Type DRUG

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

Ertugliflozin OC Fast

Intervention Type DRUG

Formulation B) Ertugliflozin 10 mg OC Fast

Ertugliflozin OC Slow

Intervention Type DRUG

Formulation C) Ertugliflozin 10 mg OC Slow

Ertugliflozin 10 mg: OC slow→tablet→OC fast

The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.

Group Type EXPERIMENTAL

Ertugliflozin 10 mg tablet

Intervention Type DRUG

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

Ertugliflozin OC Fast

Intervention Type DRUG

Formulation B) Ertugliflozin 10 mg OC Fast

Ertugliflozin OC Slow

Intervention Type DRUG

Formulation C) Ertugliflozin 10 mg OC Slow

Ertugliflozin 10 mg: OC slow→OC fast→tablet

The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.

Group Type EXPERIMENTAL

Ertugliflozin 10 mg tablet

Intervention Type DRUG

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

Ertugliflozin OC Fast

Intervention Type DRUG

Formulation B) Ertugliflozin 10 mg OC Fast

Ertugliflozin OC Slow

Intervention Type DRUG

Formulation C) Ertugliflozin 10 mg OC Slow

Interventions

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Ertugliflozin 10 mg tablet

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

Intervention Type DRUG

Ertugliflozin OC Fast

Formulation B) Ertugliflozin 10 mg OC Fast

Intervention Type DRUG

Ertugliflozin OC Slow

Formulation C) Ertugliflozin 10 mg OC Slow

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes