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

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

Detailed Description
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Pharmacokinetics and pharmacodynamics of metformin without coadministration of nilotinib will be compared with those after administration of nilotinib.

Official Title
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A Clinical Trial to Evaluate the Effect of Nilotinib on the Pharmacokinetics and Pharmacodynamics of Metformin in Healthy Male Adults

Conditions
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Healthy

Intervention / Treatment
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* Drug: Metformin
* Drug: Metformin + Nilotinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>Period 1: metformin; Period 2: metformin + nilotinib | Drug: Metformin<br>* Single administration of metformin<br>Drug: Metformin + Nilotinib<br>* Coadministration of metformin and nilotinib<br>|
| Experimental: Sequence B<br>Period 1: metformin + nilotinib; Period 2: metformin | Drug: Metformin<br>* Single administration of metformin<br>Drug: Metformin + Nilotinib<br>* Coadministration of metformin and nilotinib<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | maximum concentration | 24 hours post-dose | 
| AUCinf | Area under the concentration-time curve from time of administration extrapolated to infinity | 24 hours post-dose | 
| Gmax | maximum glucose level during oral glucose tolerance test | 3 hours from 2 hour post-dose | 
| AUGC | Area under the concentration-time curve during oral glucose tolerance test | 3 hours from 2 hour post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste test |  | 7 hour post-dose |