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Completed

NCT Number: NCT01018823

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

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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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

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 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

Treatment and study plan

Ertugliflozin

Drug

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

Other names: PF-04971729, MK-8835

Placebo to Ertugliflozin

Drug

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

Primary outcomes

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

    Time frame: Up to 28 days postdose (Up to 42 days)

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

    Time frame: Up to 14 days

  3. Area under the plasma concentration-time curve (AUC) over the dosing interval tau (AUCtau) for ertugliflozin

    Time frame: Up to 17 days

  4. Maximum plasma concentration (Cmax) of ertugliflozin

    Time frame: Up to 17 days

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

    Time frame: Up to 17 days

  6. Ertugliflozin half life (t1/2)

    Time frame: Up to 17 Days

  7. Apparent clearance (CL/F) after a single dose of ertugliflozin

    Time frame: Up to 17 days

  8. Apparent volume of distribution (Vz/F)

    Time frame: Up to 17 days

  9. Observed Accumulation Ratio of Area Under the Curve for the dosing interval of ertugliflozin (Rac[obs])

    Time frame: Up to 17 days

  10. Change from baseline in 24-hour weighted mean glucose

    Time frame: Baseline and Day 14

  11. Change from baseline in 24-hour urinary glucose excretion

    Time frame: Baseline and Day 14

  12. Change from baseline in 24-hour plasma C-peptide

    Time frame: Baseline and Day 14

  13. Inhibition of glucose reabsorption

    Time frame: Baseline and Day 14

  14. Change from baseline in body weight

    Time frame: Baseline and Day 14

  15. Area under the plasma concentration-time curve over 8 hours (AUC[0-8]) for serum intact parathyroid hormone

    Time frame: Up to 17 days

  16. Area under the plasma concentration-time curve over 24 hours (AUC[0-24]) for serum intact parathyroid hormone

    Time frame: Up to 17 days

  17. Trough concentration of serum intact parathyroid hormone (Ctrough)

    Time frame: Up to 17 days

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Pfizer

Registry information

Official study title

A Phase 1, Randomized, Placebo-Controlled, Parallel Group, 14 Day Repeated Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04971729 In Otherwise Healthy Overweight And Obese Adult Subjects

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 25, 2009
Registry last updated
May 29, 2020

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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