DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin

The purpose of this study is to investigate the impact of itraconzaole on the pharmacokinetics of Dorzagliatin.

Completed

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Key information

Conditions

Drug Interaction

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The 2nd Hospital of Jilin University

Changchun, Jilin, 130021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 30-65
Body weight ≥ 50 kg
BMI ≥ 19.0 kg/m2 and ≤ 30.0 kg/m2
HbA1c ≥ 7% and ≤ 10.5%
FPG ≥ 7.5 mmol/L and ≤ 13.3 mmol/L

Exclusion criteria

T1DM
Use of prescription or OTC medications, and herbal within 14 days prior to dosing
Blood donation
Any surgery or treatment that may impact the ADME of the drug

Treatment and study plan

Dorzagliatin

Drug

GKA for T2DM currently under clinical development

Other names: HMS5552

Primary outcomes

Cmax

Time frame: up to 96 hours

Peak concentration
AUClast

Time frame: up to 96 hours

Area under the curve

Sponsors and collaborators

Lead sponsor

Hua Medicine Limited

Industry

Registry information

Official study title

A Single Dose, Open Label, Drug-drug Interaction Study to Investigate the Pharmacokinetics, Pharmadynamics and Safety of HMS5552 Administered Alone or in Combination With Itraconazole in Patients With Type 2 Diabetes Mellitus

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Sep 6, 2019
Registry last updated: Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed