Drug InteractionPhase 1NCT04080596
DDI Study to Investigate the Impact of Itraconazole on the Pharmacokinetics of Dorzagliatin
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 study is to investigate the impact of itraconzaole on the pharmacokinetics of Dorzagliatin. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- 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
- 18 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2017to 5 Dec 2017
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to investigate the impact of itraconzaole 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
Also called HMS5552
GKA for T2DM currently under clinical development
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dorzagliatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak concentration
Measured: up to 96 hours
AUClast
Area under the 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 start13 Oct 2017
- Primary completion5 Dec 2017
- Study completion5 Dec 2017
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
- 18 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
- NCT04080596
- Sponsor's protocol ID
- HMM0107
- Status last verified
- Sep 2019
- First submitted
- 4 Sep 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- 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, Pharmadynamics and Safety of HMS5552 Administered Alone or in Combination With Itraconazole in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04080596
- Acronym / sponsor ID
- HMM0107
- Conditions
- Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hua Medicine LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 5 Dec 2017 (actual)
- Study completion
- 5 Dec 2017 (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 study is to investigate the impact of itraconzaole 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 administered alone on Day 1; after wash-out, intraconazole was administered from Day 8 to Day 15, with Dorzagliatin administered together on Day 11. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| DorzagliatinAlso: HMS5552GKA for T2DM currently under clinical development | Drug | Sequential arm |
Primary outcome
Cmax
Time frame: up to 96 hours
Peak concentration
AUClast
Time frame: up to 96 hours
Area under the 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 5 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.