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

November 3, 2020 updated by: Hyewon Chung

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Guro-gu
      • Seoul, Guro-gu, Korea, Republic of, 08308
        • Korea University Guro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Taste test
Time Frame: 7 hour post-dose
7 hour post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyewon Chung

Investigators

  • Principal Investigator: Hyewon Chung, MD, PhD, Clinical Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2020

Primary Completion (Actual)

September 7, 2020

Study Completion (Actual)

September 7, 2020

Study Registration Dates

First Submitted

June 24, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 26, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NM-DDI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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