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

Sponsor
Hua Medicine Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT04080596
Collaborator
(none)
18
Enrollment
1
Location
1
Arm
1.7
Actual Duration (Months)
10.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Oct 13, 2017
Actual Primary Completion Date :
Dec 5, 2017
Actual Study Completion Date :
Dec 5, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cmax [up to 96 hours]

      Peak concentration

    2. AUClast [up to 96 hours]

      Area under the curve

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The 2nd Hospital of Jilin University Changchun Jilin China 130021

    Sponsors and Collaborators

    • Hua Medicine Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hua Medicine Limited
    ClinicalTrials.gov Identifier:
    NCT04080596
    Other Study ID Numbers:
    • HMM0107
    First Posted:
    Sep 6, 2019
    Last Update Posted:
    Sep 6, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 6, 2019