A Clinical Trial to Evaluate the Effect of Nilotinib on the PK/PD of Meformin

• Status: Completed
• Trial end date: 2020-09-07
• Target enrollment: 0
• Participant gender: Male

Summary

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

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

Details

• Lead Sponsor: Hyewon Chung
• Treatments: Metformin

Criteria

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