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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Ertugliflozin; Drug: Placebo to Ertugliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01018823

8835-037

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 5 patient groups, including a placebo group

Ertugliflozin 1 mg

Experimental group

Description:

Ertugliflozin 1 mg, oral, once daily for 14 days

Treatment:

Drug: Ertugliflozin

Ertugliflozin up to 5 mg

Experimental group

Description:

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

Treatment:

Drug: Ertugliflozin

Ertugliflozin up to 25 mg

Experimental group

Description:

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

Treatment:

Drug: Ertugliflozin

Ertugliflozin up to 100 mg

Experimental group

Description:

Ertugliflozin up to 100 mg, once daily for 14 days

Treatment:

Drug: Ertugliflozin

Placebo

Placebo Comparator group

Description:

Placebo to Ertugliflozin once daily for 14 days

Treatment:

Drug: Placebo to Ertugliflozin