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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Metformin; Drug: Metformin + Nilotinib

• Registration Number: NCT04448821
• Lead Sponsor: Hyewon Chung

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.

Study Timeline

• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-26
• Study Start: 2020-07-23
• Primary Completion: 2020-09-07
• Study Completion: 2020-09-07
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence B	Metformin + Nilotinib	Period 1: metformin + nilotinib; Period 2: metformin
Sequence A	Metformin + Nilotinib	Period 1: metformin; Period 2: metformin + nilotinib
Sequence A	Metformin	Period 1: metformin; Period 2: metformin + nilotinib
Sequence B	Metformin	Period 1: metformin + nilotinib; Period 2: metformin

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Taste test	7 hour post-dose

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Guro-gu, Korea, Republic of