Type 2 Diabetes MellitusPhase 1NCT04426708
A Clinical Study to Access the Pharmacokinetics of HMS5552 in Hepatic Impaired Subjects and Healthy Volunteers
A Phase 1 study testing HMS5552 in people with Type 2 Diabetes Mellitus, run by Hua Medicine Limited at 1 site in China.
Trial summary
The objectives of this study is to access the pharmacokinetics and safety of HMS5552 in single dose in mild and moderate hepatic impaired subjects and matched healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- HMS5552
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2019to 3 Jul 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For hepatic impaired subjects:
- Male and female subjects between ages of 18 and 65 years, no less than 3 subjects in each gender.
- Body weight≥50kg for male and ≥45kg for female； BMI: 18.5~30 kg/m2
- ALT>2×normal upper limit (ULN), or TBiL>1.5×ULN, or diagnosed cirrhosis. The related clinical manifestations have been stable for 4-12 weeks, and Child-Pugh score is in grade A or B:
- A= mild liver damage (Group A): Child-Pugh 5-6; B= moderate liver damage (Group B): Child-Pugh 7-9;
- Willing to sign the informed consent form (ICF) and take reliable contraceptive measures within 6 months after taking the last dose of study drug;
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- Willing to adhere to the protocol requirement.
- For healthy volunteers:
- Male and female subjects between ages of 18 and 65 years, no less than 3 subjects in each gender;
- Body weight≥50kg for male and ≥45kg for female； BMI: 18.5~30 kg/m2;
- Gender, age (±5 years) and BMI (±15%) matched with corresponding subject in hepatic impaired group;
- Normal physical conditions, vital signs,12 lead ECG and laboratory recording;
- Willing to sign the informed consent form (ICF) and take reliable contraceptive measures within 6 months after taking the last dose of study drug;
- Willing to adhere to the protocol requirement.
Who cannot join
- Subjects with impaired hepatic function cannot be enrolled if they meet one of the following criteria:
- Liver cancer, liver transplantation, liver failure, autoimmune liver disease, biliary cirrhosis, or drug-induced liver damage;
- History of allergy;
- Investigators adjudicate subjects have surgery that may affect drug absorption, distribution, metabolism or excretion;
- In addition to diseases and complications of impaired hepatic function, investigator adjudicate subjects have clinically meaningful or unstable diseases or complications of central nervous system, cardiovascular system, digestive system, endocrine system, respiratory system, urinary system, blood system, mental disease, or malignant tumor, etc;
- Abnormal of ECG performance or laboratory recording during screening;
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- Family history of QT prolongation syndrome;
- History of hepatic encephalopathy or hepatic coma within 6 months before screening;
- More than 5 cigarettes per day within 3 months before screening;
- Alcohol addicts;
- History of drug abuse
- Healthy subjects cannot be enrolled if they meet one of the following criteria:
- History of allergy;
- Investigators adjudicate subjects have surgery that may affect drug absorption, distribution, metabolism or excretion;
- Investigator adjudicate subjects have clinically meaningful or unstable diseases or complications of central nervous system, cardiovascular system, digestive system, endocrine system, respiratory system, urinary system, blood system, mental disease, or malignant tumor, etc;
- Abnormal of ECG performance or laboratory recording during screening;
- Family history of QT prolongation syndrome;
- Severe infection, severe trauma or major surgery judged by investigator within 3 months before screening;
- More than 5 cigarettes per day within 3 months before screening;
- Alcohol addicts;
- History of drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Paralleled Study of the Pharmacokinetics of HMS5552 Following a Single Oral Dose in Mild and Moderate Hepatic Impaired Subjects and Matched Healthy Volunteers
The objectives of this study is to access the pharmacokinetics and safety of HMS5552 in single dose in mild and moderate hepatic impaired subjects and matched healthy adult subjects.
Read the detailed description
This is an open-label and paralleled study with single oral dose of HMS5552 given to hepatic impaired subjects and matched healthy volunteers.
The primary objective is to access the pharmacokinetic profiles of HMS5552 in 25 mg dose in hepatic impaired subjects and (gender, age and BMI) matched healthy adult subjects.
The secondary objective is to characterize the safety profiles of HMS5552 in single dose in hepatic impaired subjects.
The subjects include mild hepatic impaired subjects (A group), moderate hepatic impaired subjects (B group), and healthy subjects (C Group) matched with hepatic impaired subjects in gender, age and BMI. The number of subjects in each group was no less than 8, and no less than 3 subjects in each gender.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- HMS5552
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMS5552Drug
single dose of HMS5552 25mg
| Study group | Role | What they receive |
|---|---|---|
| Mild hepatic impaired subjects (A) | Experimental | Mild hepatic impaired subjects: to receive a single dose of HMS5552 ( 25mg ) tablet orally Receives: Drug: HMS5552 |
| Moderate hepatic impaired subjects (B) | Experimental | Moderate hepatic impaired subjects: to receive a single dose of HMS5552 ( 25mg ) tablet orally Receives: Drug: HMS5552 |
| Healthy volunteers (C) | Experimental | Matched healthy volunteers: to receive a single dose of HMS5552 ( 25mg ) tablet orally Receives: Drug: HMS5552 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Cmax;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Measured: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUClast;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Measured: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Measured: Up to 72 hours post-dose
Secondary outcomes (8)
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Cmax,u
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Measured: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUClast,u
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Measured: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf,u
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Measured: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Tmax ;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Measured: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of T1/2;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Measured: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of CL/F;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Measured: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Vz/F;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Measured: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of fu;
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
Measured: Up to 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start18 Feb 2019
- Primary completion3 Jul 2020
- Study completion3 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT04426708
- Sponsor's protocol ID
- HMM0109
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Paralleled Study of the Pharmacokinetics of HMS5552 Following a Single Oral Dose in Mild and Moderate Hepatic Impaired Subjects and Matched Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04426708
- Acronym / sponsor ID
- HMM0109
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hua Medicine LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 3 Jul 2020 (actual)
- Study completion
- 3 Jul 2020 (actual)
- First posted
- 11 Jun 2020 (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 objectives of this study is to access the pharmacokinetics and safety of HMS5552 in single dose in mild and moderate hepatic impaired subjects and matched healthy adult subjects.
Detailed description
This is an open-label and paralleled study with single oral dose of HMS5552 given to hepatic impaired subjects and matched healthy volunteers.
The primary objective is to access the pharmacokinetic profiles of HMS5552 in 25 mg dose in hepatic impaired subjects and (gender, age and BMI) matched healthy adult subjects.
The secondary objective is to characterize the safety profiles of HMS5552 in single dose in hepatic impaired subjects.
The subjects include mild hepatic impaired subjects (A group), moderate hepatic impaired subjects (B group), and healthy subjects (C Group) matched with hepatic impaired subjects in gender, age and BMI. The number of subjects in each group was no less than 8, and no less than 3 subjects in each gender.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild hepatic impaired subjects (A) | Experimental | Drug: HMS5552Mild hepatic impaired subjects: to receive a single dose of HMS5552 ( 25mg ) tablet orally |
| Moderate hepatic impaired subjects (B) | Experimental | Drug: HMS5552Moderate hepatic impaired subjects: to receive a single dose of HMS5552 ( 25mg ) tablet orally |
| Healthy volunteers (C) | Experimental | Drug: HMS5552Matched healthy volunteers: to receive a single dose of HMS5552 ( 25mg ) tablet orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- For hepatic impaired subjects:
- A= mild liver damage (Group A): Child-Pugh 5-6; B= moderate liver damage (Group B): Child-Pugh 7-9;
- For healthy volunteers:
Key exclusion criteria (21 listed)
- Subjects with impaired hepatic function cannot be enrolled if they meet one of the following criteria:
- Healthy subjects cannot be enrolled if they meet one of the following criteria:
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 |
|---|---|---|
| HMS5552single dose of HMS5552 25mg | Drug | Healthy volunteers (C), Mild hepatic impaired subjects (A), Moderate hepatic impaired subjects (B) |
Primary outcome
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Cmax;
Time frame: Up to 72 hours post-dose
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUClast;
Time frame: Up to 72 hours post-dose
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf;
Time frame: Up to 72 hours post-dose
Plasma will be collected at predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hour post-dose.
8 secondary outcomes
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Cmax,u
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUClast,u
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of AUCinf,u
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Tmax ;
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of T1/2;
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of CL/F;
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Vz/F;
Time frame: Up to 72 hours post-dose
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of fu;
Time frame: Up to 72 hours post-dose
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 29 Nov 2022.
- 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 HMS5552 in people with Type 2 Diabetes Mellitus, 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 14 inclusion and 21 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 29 Nov 2022. 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?
The single dose pharmacokinetics of HMS5552 will be described by estimating parameters of Cmax; (time frame: Up to 72 hours post-dose). The study lists 3 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 29 Nov 2022.