A Clinical Trial to Evaluate the Effect of Nilotinib on the Pharmacokinetics and Pharmacodynamics of Metformin in Healthy Male Adults
Overview
- Phase
- Phase 1
- Intervention
- Metformin + Nilotinib
- Conditions
- Healthy
- Sponsor
- Hyewon Chung
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- AUGC
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Hyewon Chung
Clinical Assistant Professor
Korea University Guro Hospital
Eligibility 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
Arms & Interventions
Sequence A
Period 1: metformin; Period 2: metformin + nilotinib
Intervention: Metformin + Nilotinib
Sequence A
Period 1: metformin; Period 2: metformin + nilotinib
Intervention: Metformin
Sequence B
Period 1: metformin + nilotinib; Period 2: metformin
Intervention: Metformin
Sequence B
Period 1: metformin + nilotinib; Period 2: metformin
Intervention: Metformin + Nilotinib
Outcomes
Primary Outcomes
AUGC
Time Frame: 3 hours from 2 hour post-dose
Area under the concentration-time curve during oral glucose tolerance test
AUCinf
Time Frame: 24 hours post-dose
Area under the concentration-time curve from time of administration extrapolated to infinity
Gmax
Time Frame: 3 hours from 2 hour post-dose
maximum glucose level during oral glucose tolerance test
Cmax
Time Frame: 24 hours post-dose
maximum concentration
Secondary Outcomes
- Taste test(7 hour post-dose)