NCT04080609

Brief Summary

The purpose of this drug-drug interaction study is to investigate the impact of rifampicin on the pharmacokinetics of Dorzagliatin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2018

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2018

Completed
1.4 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

21 days

First QC Date

September 4, 2019

Last Update Submit

September 4, 2019

Conditions

Drug Interaction

Outcome Measures

Primary Outcomes (2)

  • Cmax

    Peak plasma concentration

    up to 96 hours

  • AUClast

    Area under the plasma concentration curve

    up to 96 hours

Study Arms (1)

Sequential arm

EXPERIMENTAL

Dorzagliatin was administered single dose; after wash-out, rifampicin was dosed continuously for 9 days, with Dorzagliatin dosed simultaneously on day 8.

Drug: Dorzagliatin

Interventions

DorzagliatinDRUG

GKA currently under clinical development

Sequential arm

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body weight ≥ 50 kg (male) or ≥ 45 kg (female)
  • BMI within 19～26 kg/m2

You may not qualify if:

  • History or disease status that may impact the ADME of the study
  • Use of any drugs, OTCs, or hebal within 4 weeks of screening
  • Drug abuse
  • Blood donation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Hospital of Xuhui District

Shanghai, Shanghai Municipality, 201203, 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

March 27, 2018

Primary Completion

April 17, 2018

Study Completion

April 17, 2018

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)