A Phase 1 Study of Ertugliflozin in Healthy Male Participants (MK-8835-020)

• Status: Completed
• Trial end date: 2015-02-09
• Target enrollment: 0
• Participant gender: Male

Summary

This study will evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of ertugliflozin following oral administration of unlabeled ertugliflozin (MK-8835) and intravenous (IV) and oral administration of 14^C-labeled ertugliflozin in healthy male participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Pfizer
• Treatments: Ertugliflozin

Criteria

Inclusion Criteria:

• Healthy male subjects between the ages of 18 and 65 years.

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; 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).

• Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).

• A positive urine drug screen for drugs of abuse or recreational drugs.

• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.

• History of abuse of alcohol or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.

• Current smokers and those who have smoked any substance within the last 12 months.

• Treatment with an investigational drug within 1 month preceding the first dose of study medication.

• Have participated in any clinical study with exposure to 14^C in the last 12 months.

• Any radiation exposure, including that which is projected to result from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures. No occupationally exposed worker, as defined in the Ionising Radiation Regulation 1999, shall participate in the study.

• Use of prescription or nonprescription drugs (including vitamins and dietary supplements) within 7 days prior to the first dose of study medication.

• Use of herbal supplements within 28 days prior to the first dose of study medication.

• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.

• Participants who have previously participated in a clinical trial for ertugliflozin.

• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.