Drug InteractionPhase 1NCT04080609
DDI Study Between Dorzagliatin and Rifampicin
A Phase 1 study testing Dorzagliatin in people with Drug Interaction, run by Hua Medicine Limited at 1 site in China.
Trial summary
The purpose of this drug-drug interaction study is to investigate the impact of rifampicin on the pharmacokinetics of Dorzagliatin. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction
- What is being tested?
- Dorzagliatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2018to 17 Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight ≥ 50 kg (male) or ≥ 45 kg (female)
- BMI within 19～26 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Central Hospital of Xuhui District
Shanghai, Shanghai Municipality, 201203
About this study
Official title: A Single Dose, Open Label, Drug-drug Interaction Study to Investigate the Pharmacokinetics and Safety of Dorzagliation Administered Alone or in Combination With Rifampicin in Healthy Subjects
The purpose of this drug-drug interaction study is to investigate the impact of rifampicin on the pharmacokinetics of Dorzagliatin.
- Conditions
- Drug Interaction
- Being tested
- Dorzagliatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DorzagliatinDrug
GKA currently under clinical development
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dorzagliatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak plasma concentration
Measured: up to 96 hours
AUClast
Area under the plasma concentration curve
Measured: up to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start27 Mar 2018
- Primary completion17 Apr 2018
- Study completion17 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hua Medicine Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080609
- Sponsor's protocol ID
- HMM0108
- Status last verified
- Sep 2019
- First submitted
- 4 Sep 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Open Label, Drug-drug Interaction Study to Investigate the Pharmacokinetics and Safety of Dorzagliation Administered Alone or in Combination With Rifampicin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04080609
- Acronym / sponsor ID
- HMM0108
- Conditions
- Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hua Medicine LimitedIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 17 Apr 2018 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this drug-drug interaction study is to investigate the impact of rifampicin on the pharmacokinetics of Dorzagliatin.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential arm | Experimental | Drug: DorzagliatinDorzagliatin was administered single dose; after wash-out, rifampicin was dosed continuously for 9 days, with Dorzagliatin dosed simultaneously on day 8. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body weight ≥ 50 kg (male) or ≥ 45 kg (female)
- BMI within 19～26 kg/m2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DorzagliatinGKA currently under clinical development | Drug | Sequential arm |
Primary outcome
Cmax
Time frame: up to 96 hours
Peak plasma concentration
AUClast
Time frame: up to 96 hours
Area under the plasma concentration curve
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dorzagliatin in people with Drug Interaction, run by Hua Medicine Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: up to 96 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.