Dose Modification Requirement for Trelagliptin in Egyptian Population

Study Overview
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Brief Summary
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The proposed study will consider the pharmacokinetic evaluation of Trelagliptin after administration to Egyptian volunteers and the results will be compared with the other reported ethnic populations. The FDA recognizes that standard methods of defining racial subgroups are necessary to compare results across pharmacokinetic studies, and to assess potential subgroup differences. The design of the study is open labeled, one treatment, one period, single dose pharmacokinetic study.

Detailed Description
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The proposed study will consider the pharmacokinetic evaluation of Trelagliptin after administration to Egyptian volunteers and the results will be compared with the other reported ethnic populations. The FDA recognizes that standard methods of defining racial subgroups are necessary to compare results across pharmacokinetic studies, and to assess potential subgroup differences. The design of the study is open labeled, one treatment, one period, single dose pharmacokinetic study. The main pharmacokinetic parameters which are Cmax, Tmax, t1/2, elimination rate constant, AUC0-t and AUC0-inf, will be estimated. Fasting of all volunteers will eliminate the possible interaction from food or caffeine consumption. The pharmacokinetic parameters of Trelagliptin will be studied in healthy human subjects according to the ethical regulations of World Medical Association Declaration of Helsinki (October 1996) and the International Conference of Harmonisation Tripartite Guideline for Good Clinical Practice. Written informed consent was provided (attached and signed by the six volunteers) in order to be approved by the ethics committee of the Faculty of Pharmacy, The British University in Egypt. The good health of the human subjects was confirmed by a complete medical history and physical examination. Samples from six, healthy, adult, male, smoking, Egyptian volunteers (age: 25-39 years, average weight: 89.8 kg, Average BMI: 34.2) will be collected at 0, 0.5, 1, 1.5, 2, 2.5, 3, 8, 24, 48, 72, 96, 120, 144 and 168 hrs to be transferred to heparinized centrifuge tubes in order to be analyzed by LC-MS/MS study (developed & validated) after single oral dose administration of one Zafatek® tablet nominally containing 50 mg Trelaglipitin. The blood samples (1 mL of each sample) will be centrifuged at 3000 rpm for 5 minutes, The main pharmacokinetic parameters of the study which are Cmax, Tmax, t1/2, elimination rate constant, AUC0-t and AUC0-inf will be estimated, using a validated excel software. Blood glucose level will be determined for all volunteers at different time intervals to monitor any hypoglycemic effect. The study will be conducted as per FDA guidelines. The development of such correlations between trelagliptin concentrations and its pharmacologic responses will enable clinicians to apply pharmacokinetic principles to actual patient situations. The evaluation of safety of the study will be based on monitoring of blood glucose level, vital signs, pulse rate, monitoring of adverse events, and physical examination.

Official Title
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Dose of Trelagliptin for Egyptian Patients Requires no Modification Than Japanese

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Trelagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The good health of the human subjects was confirmed by a complete medical history and physical examination. Exclusion Criteria: Patients suffering from any chronic disease other than diabetes will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Good health of the human subjects was confirmed with a complete medical history and physical examination. Fasting of all volunteers eliminated the possible interaction from high fat meals. The evaluation of safety of the study was based on monitoring of blood glucose level, vital signs, pulse rate, monitoring of adverse events, and physical examination. Samples from 6 healthy, adult, male, Egyptian volunteers (age: 25-39 years, average weight: 89.8 kg, average body mass index (BMI): 34.2) were collected at 0, 0.5, 1, 1.5, 2, 2.5, 3, 8, 24, 48, 72, 96, 120, 144 and 168 hrs, transferred to heparinized centrifuge tubes and analyzed with the proposed method after single oral dose administration of one Zafatek® tablet nominally containing 50 mg TLN. Blood samples (1 mL of each sample) were centrifuged at 3000 rpm for 5 min.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trilaglibtin 50 mg<br>Samples from 6 healthy, adult, male, Egyptian volunteers (age: 25-39 years, average weight: 89.8 kg, average body mass index (BMI): 34.2) were collected at 0, 0.5, 1, 1.5, 2, 2.5, 3, 8, 24, 48, 72, 96, 120, 144 and 168 hrs, transferred to heparinized centrifuge tubes and analyzed with the proposed method after single oral dose administration of one Zafatek® tablet nominally containing 50 mg trilagliptin. Blood samples (1 mL of each sample) were centrifuged at 3000 rpm for 5 min. | Drug: Trelagliptin<br>* Anti diabetic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | The peak plasma concentration of a drug after administration | 12 hours | 
| Tmax | Time to reach Cmax. | 12 hours | 
| Elimination half life | The time required for the concentration of the drug to reach half of its original value. | 12 hours | 
| Elimination rate constant | The rate at which a drug is removed from the body. | 12 hours | 
| Area under the curve | The integral of the concentration-time curve | 12 hours |