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

Sponsor
Hyewon Chung (Other)
Overall Status
Completed
CT.gov ID
NCT04448821
Collaborator
(none)
16
1
2
1.5
10.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Clinical Trial to Evaluate the Effect of Nilotinib on the Pharmacokinetics and Pharmacodynamics of Metformin in Healthy Male Adults
Actual Study Start Date :
Jul 23, 2020
Actual Primary Completion Date :
Sep 7, 2020
Actual Study Completion Date :
Sep 7, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Cmax [24 hours post-dose]

    maximum concentration

  2. AUCinf [24 hours post-dose]

    Area under the concentration-time curve from time of administration extrapolated to infinity

  3. Gmax [3 hours from 2 hour post-dose]

    maximum glucose level during oral glucose tolerance test

  4. AUGC [3 hours from 2 hour post-dose]

    Area under the concentration-time curve during oral glucose tolerance test

Secondary Outcome Measures

  1. Taste test [7 hour post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Korea University Guro Hospital Seoul Guro-gu Korea, Republic of 08308

Sponsors and Collaborators

  • Hyewon Chung

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hyewon Chung, Clinical Assistant Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier:
NCT04448821
Other Study ID Numbers:
  • NM-DDI
First Posted:
Jun 26, 2020
Last Update Posted:
Nov 4, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 4, 2020