Omarigliptin in Four Healthy Egyptian Volunteers

NCT ID: NCT04365907

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-11
• Study Completion Date: 2020-05-28

Brief Summary

The proposed study will consider the LC-MS/MS quantitative determination of Omarigliptin after administration to four Egyptian volunteers. The main aim of the study is to confirm that the developed LC-MS/MS method is applicable for the bio-assay of the drug in the actual biological samples at the time of Cmax (nearly about 1.5 hours). The design of the study is open labeled, one treatment, one period, single dose study. The concentration of the drugs after 1.5 h will be determined 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 four 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 four, healthy, adult, male, smoking, Egyptian volunteers (age: 23-37 years, Average weight: 81.6 kg, Average BMI: 30.4) will be collected at 1.5 h, 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 Marizev® tablet nominally containing 12.5 mg of Omarigliptin (first arm as 4 volunteers). The blood samples (1 mL of each sample) will be centrifuged at 3000 rpm for 5 minutes, 100 µL of the plasma will be separated and spiked with the internal standard working solution and then the sample preparation and LC-MS/MS determination will be applied. Blood glucose level will be determined for all volunteers at different time intervals to monitor any hypoglycemic effect to ensure their safety all over the study. The study will be conducted as per FDA guidelines & 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

Healthy Volunteers

Study Design

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

Study Groups

Omarigliptin 12.5 mg

Drug: Omarigliptin 12.5 mg Once weekly new anti-diabetic drug approved only in Japan Other Name: Zafatek tablets

Group Type: EXPERIMENTAL

Zafatek tablets

Intervention Type: DRUG

Once weekly new anti-diabetic drug approved only in Japan

Interventions

Zafatek tablets

Once weekly new anti-diabetic drug approved only in Japan

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers
• Must be able to swallow tablets

Exclusion Criteria

• Insulin dependent diabetes
• Type-2 diabetes
• Hospitalized within 1 week

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

British University In Egypt

OTHER

Sponsor Role: lead

Responsible Party

Bassam Mahfouz Ayoub

Associate Professor in Analytical Chemistry Department,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The British University in Egypt

Cairo, El-Sherouk, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Bassam Ayoub, PhD

Role: primary

Bassam.ayoub@bue.edu.eg

01225104337

Nermeen Ashoush, PhD

Role: backup

nermeen.ashoush@bue.edu.eg

01001809397

Other Identifiers

CDRD-3

Identifier Type: -

Identifier Source: org_study_id