Dose Modification Requirement for Trelagliptin in Egyptian Population

NCT ID: NCT04374864

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-07-01

Brief 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.

Detailed 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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Trilaglibtin 50 mg

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.

Group Type: EXPERIMENTAL

Trelagliptin

Intervention Type: DRUG

Anti diabetic

Interventions

Trelagliptin

Anti diabetic

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nermeen Ashoush

UNKNOWN

Sponsor Role: collaborator

Shereen Mowaka

UNKNOWN

Sponsor Role: collaborator

Mariam M. Tadros

UNKNOWN

Sponsor Role: collaborator

British University In Egypt

OTHER

Sponsor Role: lead

Responsible Party

Bassam Mahfouz Ayoub

Associate Professor in Pharmaceutical Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The British University in Egypt

Cairo, El Sherouk, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Bassam Ayoub, PhD

Role: CONTACT

bassam.ayoub@bue.edu.eg

26890000 ext. 184

Nermeen Ashoush, PhD

Role: CONTACT

nermeen.ashoush@bue.edu.eg

Facility Contacts

Bassam Ayoub, PhD

Role: primary

bassam.ayoub@bue.edu.eg

26890000 ext. 184

Other Identifiers

BUE 2020

Identifier Type: -

Identifier Source: org_study_id