NCT04080596

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

September 4, 2019

Last Update Submit

September 4, 2019

Conditions

Drug Interaction

Outcome Measures

Primary Outcomes (2)

  • Cmax

    Peak concentration

    up to 96 hours

  • AUClast

    Area under the curve

    up to 96 hours

Study Arms (1)

Sequential arm

EXPERIMENTAL

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

Interventions

DorzagliatinDRUG

GKA for T2DM currently under clinical development

Also known as: HMS5552
Sequential arm

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 2nd Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Interventions

Dorzagliatin

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2019

First Posted

September 6, 2019

Study Start

October 13, 2017

Primary Completion

December 5, 2017

Study Completion

December 5, 2017

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)