Overview

The aim of the study is to evaluate the effect of nilotinib on the pharmacokinetics and pharmacodynamics of metformin in healthy male adults

Eligibility

Inclusion Criteria:

• Healthy male subjects between the ages of 19 and 50 years
• Subjects with body mass index (BMI) between 18.5 and 29.9 kg/m2 and weight more than 50 kg
• Subjects who agree with performing contraception during the study
• Subjects who provides written informed consent

Exclusion Criteria:

• Subjects who have a current or prior history of cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, skin, psychiatric, or neurological diseases that is clinically significant
• Subjects who have clinically significant allergic history or allergy to metformin, nilotinib, or other components of drug
• Subjects with history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
• Subjects with hypokalemia or hypomagnesemia at screening
• Subjects with QTcF > 450 or clinically significant findings on 12-lead ECG at screening
• Subjects with fasting plasma glucose lower than 70 mg/dL or upper than 126 mg/dL at screening
• Subjects who have history of gastrointestinal surgery
• Subjects with creatinine clearance 60mL/min at screening
• Subjects with AST or ALT 2-folds of upper normal limit
• Subjects who reports less than 12 points on taste test at screening
• Subjects who have administrated drugs that are known to cause significant drug-drug interaction with investigational drugs within 2 weeks prior to dosing
• Whole blood donation within 60 days prior to dosing, or apheresis donation within 20 days prior to dosing, or received blood donation within 30 days prior to dosing
• Subjects who participated in a previous clinical trial within 6 months prior to dosing
• Subjects with a history of alcohol abuse
• Subjects who are determined as unsuitable for clinical trial participation by investigator's decision