Status:
COMPLETED
A Clinical Trial to Evaluate the Effect of Nilotinib on the PK/PD of Meformin
Lead Sponsor:
Hyewon Chung
Conditions:
Healthy
Eligibility:
MALE
19-50 years
Phase:
PHASE1
Brief Summary
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
Pharmacokinetics and pharmacodynamics of metformin without coadministration of nilotinib will be compared with those after administration of nilotinib.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04448821
Start Date
July 23 2020
End Date
September 7 2020
Last Update
November 4 2020
Active Locations (1)
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1
Korea University Guro Hospital
Seoul, Guro-gu, South Korea, 08308