Clinical trial NCT04448821: A Clinical Trial to Evaluate the Effect of Nilotinib on the PK/PD of Meformin
Official title: A Clinical Trial to Evaluate the Effect of Nilotinib on the Pharmacokinetics and Pharmacodynamics of Metformin in Healthy Male Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 16
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Cmax
timeFrame: 24 hours post-dose
measure: AUCinf
timeFrame: 24 hours post-dose
measure: Gmax
timeFrame: 3 hours from 2 hour post-dose
measure: AUGC
timeFrame: 3 hours from 2 hour post-dose
Secondary outcomes:
measure: Taste test
timeFrame: 7 hour post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Guro-gu
Study officials:
affiliation: Clinical Assistant Professor
name: Hyewon Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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