Dose Modification Requirement for Trelagliptin in Egyptian Population

NCT04374864 | Unknown Phase 4 DMC

• 1 other identifier: BUE 2020
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Trilaglibtin 50 mg

EXPERIMENTAL

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

Interventions

Trelagliptin DRUG

Anti diabetic

Trilaglibtin 50 mg

Eligibility Criteria

• Age: 25 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The good health of the human subjects was confirmed by a complete medical history and physical examination.

You may not qualify if:

• Patients suffering from any chronic disease other than diabetes will be excluded from the study.

Sponsors & Collaborators

• British University In Egypt: lead
• Nermeen Ashoush: collaborator
• Shereen Mowaka: collaborator
• Mariam M. Tadros: collaborator

Study Sites (1)

The British University in Egypt

Cairo, El Sherouk, 11837, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

trelagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Bassam Ayoub, PhD

CONTACT

26890000; bassam.ayoub@bue.edu.eg

Nermeen Ashoush, PhD

CONTACT

nermeen.ashoush@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Pharmaceutical Department

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 5, 2020
• Study Start: March 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-05

Locations

EG (1)