Omarigliptin in Four Healthy Egyptian Volunteers

NCT04365907 | Unknown DMC

• 1 other identifier: CDRD-3
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Plasma concentration (nMol/L) after 1.5 hours

  Only one determination of human plasma concentration (nM/L) of omarigliptin will be determined after 1.5 hours for the current investigation.

  1.5 hours

Study Arms (1)

Omarigliptin 12.5 mg

EXPERIMENTAL

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

Drug: Zafatek tablets

Interventions

Zafatek tablets DRUG

Once weekly new anti-diabetic drug approved only in Japan

Omarigliptin 12.5 mg

Eligibility Criteria

• Age: 23 Years - 37 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers
• Must be able to swallow tablets

You may not qualify if:

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

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The British University in Egypt

Cairo, El-Sherouk, 11837, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Analytical Chemistry Department,

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 28, 2020
• Study Start: March 11, 2020
• Primary Completion: May 20, 2020
• Study Completion: May 28, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

EG (1)