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HealthyPhase 1NCT04448821

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

A Phase 1 study testing Metformin and Metformin + Nilotinib in people with Healthy, run by Hyewon Chung at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 19 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Metformin and Metformin + Nilotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteSouth Korea
Study dates
23 Jul 2020to 7 Sep 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University Guro Hospital

    Seoul, Guro-gu, 08308

Other trials in South Korea

About this study

Official title: 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

Read the detailed description

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

Conditions
Healthy
Being tested
Metformin, Metformin + Nilotinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Single administration of metformin

  • Metformin + NilotinibDrug

    Coadministration of metformin and nilotinib

Study groups in NCT04448821
Study groupRoleWhat they receive
Sequence AExperimentalPeriod 1: metformin; Period 2: metformin + nilotinib
Receives: Drug: Metformin; Drug: Metformin + Nilotinib
Sequence BExperimentalPeriod 1: metformin + nilotinib; Period 2: metformin
Receives: Drug: Metformin; Drug: Metformin + Nilotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    maximum concentration

    Measured: 24 hours post-dose

  2. AUCinf

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

    Measured: 24 hours post-dose

  3. Gmax

    maximum glucose level during oral glucose tolerance test

    Measured: 3 hours from 2 hour post-dose

  4. AUGC

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

    Measured: 3 hours from 2 hour post-dose

Secondary outcomes (1)

  1. Taste test

    Measured: 7 hour post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2020
  2. Study start23 Jul 2020
  3. Primary completion7 Sep 2020
  4. Study completion7 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04448821
Sponsor's protocol ID
NM-DDI
Status last verified
Nov 2020
First submitted
24 Jun 2020
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Graham GG, Punt J, Arora M, Day RO, Doogue MP, Duong JK, Furlong TJ, Greenfield JR, Greenup LC, Kirkpatrick CM, Ray JE, Timmins P, Williams KM. Clinical pharmacokinetics of metformin. Clin Pharmacokinet. 2011 Feb;50(2):81-98. doi: 10.2165/11534750-000000000-00000.

    PubMed 21241070

  • Chen EC, Liang X, Yee SW, Geier EG, Stocker SL, Chen L, Giacomini KM. Targeted disruption of organic cation transporter 3 attenuates the pharmacologic response to metformin. Mol Pharmacol. 2015 Jul;88(1):75-83. doi: 10.1124/mol.114.096776. Epub 2015 Apr 28.

    PubMed 25920679

  • Kwon EY, Chung JY, Park HJ, Kim BM, Kim M, Choi JH. OCT3 promoter haplotype is associated with metformin pharmacokinetics in Koreans. Sci Rep. 2018 Nov 16;8(1):16965. doi: 10.1038/s41598-018-35322-6.

    PubMed 30446679

  • Lapczuk-Romanska J, Busch D, Gieruszczak E, Drozdzik A, Piotrowska K, Kowalczyk R, Oswald S, Drozdzik M. Membrane Transporters in Human Parotid Gland-Targeted Proteomics Approach. Int J Mol Sci. 2019 Sep 28;20(19):4825. doi: 10.3390/ijms20194825.

    PubMed 31569384

  • Lee N, Duan H, Hebert MF, Liang CJ, Rice KM, Wang J. Taste of a pill: organic cation transporter-3 (OCT3) mediates metformin accumulation and secretion in salivary glands. J Biol Chem. 2014 Sep 26;289(39):27055-27064. doi: 10.1074/jbc.M114.570564. Epub 2014 Aug 8.

    PubMed 25107910

  • Minematsu T, Giacomini KM. Interactions of tyrosine kinase inhibitors with organic cation transporters and multidrug and toxic compound extrusion proteins. Mol Cancer Ther. 2011 Mar;10(3):531-9. doi: 10.1158/1535-7163.MCT-10-0731. Epub 2011 Jan 20.

    PubMed 21252289

  • Rhee SJ, Choi Y, Lee S, Oh J, Kim SJ, Yoon SH, Cho JY, Yu KS. Pharmacokinetic and pharmacodynamic interactions between metformin and a novel dipeptidyl peptidase-4 inhibitor, evogliptin, in healthy subjects. Drug Des Devel Ther. 2016 Aug 10;10:2525-34. doi: 10.2147/DDDT.S110712. eCollection 2016.

    PubMed 27570447

  • Jang K, Chung H, Yoon JS, Moon SJ, Yoon SH, Yu KS, Kim K, Chung JY. Pharmacokinetics, Safety, and Tolerability of Metformin in Healthy Elderly Subjects. J Clin Pharmacol. 2016 Sep;56(9):1104-10. doi: 10.1002/jcph.699. Epub 2016 Feb 22.

    PubMed 26710683

  • Hwang CS, Kim JW, Al Sharhan SS, Kim JW, Cho HJ, Yoon JH, Kim CH. Development of a Gustatory Function Test for Clinical Application in Korean Subjects. Yonsei Med J. 2018 Mar;59(2):325-330. doi: 10.3349/ymj.2018.59.2.325.

    PubMed 29436203

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Metformin and Metformin + Nilotinib in people with Healthy, run by Hyewon Chung at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: 24 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04448821, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.

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