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

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

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

Study Overview

• Status: Completed
• Conditions: Drug Interaction
• Intervention / Treatment: Drug: Dorzagliatin

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • The 2nd hospital of JiLin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sequential arm; Dorzagliatin administered alone on Day 1; after wash-out, intraconazole was administered from Day 8 to Day 15, with Dorzagliatin administered together on Day 11.	Drug: Dorzagliatin; GKA for T2DM currently under clinical development; Other Names: HMS5552

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Peak concentration	up to 96 hours
AUClast	Area under the curve	up to 96 hours

Collaborators and Investigators

• Sponsor: Hua Medicine Limited

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 13, 2017
• Primary Completion (ACTUAL): December 5, 2017
• Study Completion (ACTUAL): December 5, 2017

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (ACTUAL): September 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HMM0107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No