Dose Modification Requirement for Trelagliptin in Egyptian Population

Diabetes Mellitus Clinical Trial

— Trelagliptin  

Official title:

Dose of Trelagliptin for Egyptian Patients Requires no Modification Than Japanese

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04374864
• Other study ID #: BUE 2020
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: May 2020
• Source: British University In Egypt
• Contact: Bassam Ayoub, PhD
• Phone: 26890000
• Email: bassam.ayoub[@]bue.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Trelagliptin
Anti diabetic

Locations

Country	Name	City	State
Egypt	The British University in Egypt	Cairo	El Sherouk

Sponsors (4)

Lead Sponsor	Collaborator
British University In Egypt	Mariam M. Tadros, Nermeen Ashoush, Shereen Mowaka

Country where clinical trial is conducted

Egypt, 

Outcome

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