Effect of Glucuronosyltransferase (UGT) Genetic Variation on Pharmacokinetics of Empagliflozin

NCT05036421 | Completed Phase 3 DMC

• 1 other identifier: PHCL277
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this works is to investigate the effect of genetic polymorphism of snps on human response to treatment with empagliflozin and its correlation with with pharmacokinetic parameters in Egyptian subjects

Conditions

Pharmacogenomic; Pharmacokinetics

Keywords

UGT polymorphism; Pharmacokinetics; Empagliflozin

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic parameters

  AUC0→∞

  48 hours

• Bioavailability parameters

  Cmax

  24 hours

Secondary Outcomes (1)

• Secondary outcome

  48 hours

Study Arms (1)

Study Group

EXPERIMENTAL

Empagliflozin

Drug: Empagliflozin 10 milligram

Interventions

Empagliflozin 10 milligram DRUG

antihyperglycemic medication

Also known as: Jardiance

Study Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult volunteers
• Age between (18-45 years)
• Normal BMI.
• Understand the procedures and are willing to participate and gave their final written consent prior to the commencement of the study procedures.
• The volunteers will be asked to provide a complete medical history, and complete a physical examination, laboratory tests \[hematology, clinical chemistry, urinalysis, serology (including hepatitis B surface antigen, anti-hepatitis C virus and antihuman immunodeficiency virus antibody).

You may not qualify if:

• Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.
• Subjects who have taken any medication less than two weeks of the trials starting date.
• Susceptibility to allergic reactions to study drugs.
• Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.
• Gastrointestinal diseases.
• Renal diseases.
• Cardiovascular diseases.
• Pancreatic disease including diabetes.
• Hepatic diseases.
• Hematological disease or pulmonary disease
• Abnormal laboratory values.
• Subjects who have donated blood or who have been involved in multiple dosing study requiring a large volume of blood (more than 500 ml) to be drawn within 6 weeks preceding the start of the study.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Pharmacy

Cairo, Egypt

Location

MeSH Terms

Interventions

empagliflozin

Study Officials

• Sara M Shaheen, Assiss. Prof

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open label, single-dose, one-period, design

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 5, 2021
• Study Start: February 15, 2022
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)