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

  • STATUS
    Recruiting
  • participants needed
    16
  • sponsor
    Hyewon Chung
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Updated on 5 August 2020
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body mass index
metformin

Summary

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

Description

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

Details
Condition Healthy
Age 19years - 50years
Treatment Metformin, Metformin + Nilotinib
Clinical Study IdentifierNCT04448821
SponsorHyewon Chung
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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