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Completed

NCT Number: NCT01114568

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

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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Key information

Conditions

Healthy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ertugliflozin 10 mg tablet

Drug

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

Ertugliflozin OC Fast

Drug

Formulation B) Ertugliflozin 10 mg OC Fast

Ertugliflozin OC Slow

Drug

Formulation C) Ertugliflozin 10 mg OC Slow

Primary outcomes

  1. Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin

    Time frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period)

  2. AUC from Hour 0 to infinity (AUCinf) for ertugliflozin

    Time frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period)

  3. Maximum plasma concentration (Cmax) of ertugliflozin

    Time frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period)

  4. Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin

    Time frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period)

  5. Ertugliflozin half life (t1/2)

    Time frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period)

  6. Number of Participants Experiencing an Adverse Event (AE)

    Time frame: Up to 28 days postdose (Up to 49 days)

  7. Number of Participants Discontinuing Study Drug Due to an AE

    Time frame: Up to Day 21

  8. Urinary glucose excretion

    Time frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 3, 2010
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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