Hepatic ImpairmentPhase 1NCT04859426
A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Hepatic Impairment
A Phase 1 study testing DBPR108 tablets in people with Hepatic Impairment, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild or moderate hepatic impairment (HI) compared to the matched control subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- DBPR108 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2021to 17 May 2022
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects:
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions；
- 18 years to 79 years (inclusive), male or female；
- Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-30 kg/m2 (inclusive) (BMI= weight (kg)/height 2 (m2))；
- Subjects (including partners) are willing to use effective contraceptives from screening to the 6 months after the last dose administration；
- Subjects with HI only:
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- Medically stable hepatic impairment on the Child-Pugh Class A (mild) or Child-Pugh Class B (moderate) caused by a primary hepatic disease;
- Not in use of any prescription drug, over-the-counter drug, or herbal medicine within 2 weeks prior to screening, except for the medication necessary for hepatic impairment/ other comorbidities (last more than four weeks in good compliance);
- Subjects with normal liver function only:
- Weight, age, and sex must be matched with subjects with HI;
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) results within normal range;
- Not in use of any prescription drug, over-the-counter drug, or herbal medicine within 2 weeks prior to screening, except for the medication necessary for underlying conditions other than liver disease (last more than four weeks in good compliance);
Who cannot join
- All subjects:
- Subjects who have a history of allergic conditions (such as asthma, urticaria), or have a history of allergy to two or more drugs or food, or may be allergic to the test drug and the related compounds;
- Have a history of severe and uncontrolled diseases, such as cardiovascular, respiratory, gastrointestinal, endocrine, hematologic, mental/nervous systems diseases within one year prior to screening；
- Subjects who have previously undergone surgery that may affect drug absorption, distribution, metabolism, or excretion (e.g., subtotal gastrectomy), or who have a scheduled surgical plan during the study period;
- Use of any DPP-IV enzyme inhibitor within 2 weeks prior to the screening;
- Drug abuse, or positive urine drug screen at screening；
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- Smoking more than 5 cigarettes per day within 3 months prior to screening；
- Average alcohol intake is more than 28g alcohol (male) or 14g (female) per week (14g ≈ 497mL beer, or 44mL spirits with low alcohol content, or 145mL wine) within the 3 months prior to screening, or taking any alcohol within 48 hours before dosing, or a positive ethanol breath test at screening；
- Consumption of grapefruit juice, Methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks) within 48 hours before the administration, or have strenuous exercise, or have other factors affecting drug absorption, distribution, metabolism, excretion, etc.；
- Participation in another clinical trial within 3 months before screening；
- Blood donation (or blood loss) ≥400 mL, or receiving whole blood transfusions or erythrocyte suspension transfusions within 3 months prior to the screening；
- A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial；
- Estimated glomerular filtration rate (eGFR)<90 mL/min/1.73 m2 calculated by the modification of diet in renal diseases (MDRD) equation at screening；
- Have a positive test result of human immunodeficiency virus (HIV) antibody, or anti-Treponema pallidum specific antibody；
- Currently receiving, or unable to refrain from expected concomitant cytochrome (CYP) 3A inhibitors and inducers;
- Not suitable for this study as judged by the investigator；
- Subjects with HI only:
- Drug-induced liver injury；
- Acute liver injury by any cause；
- Subjects with liver failure, or subjects with cirrhosis complicated with hepatocellular carcinoma or symptomatic hepatic encephalopathy, etc., are deemed as unsuitable for this study by the investigator；
- Subjects with normal liver function only:
- History of HI, or presence of abnormal results in physical examination and laboratory examination at screening that may indicate any liver illness in the opinion of the Investigator;
- Have a positive test result of hepatitis B surface antigen, or hepatitis C antibody.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-dose, Phase I Study to Assess the Pharmacokinetics and Safety of DBPR108 Tablets in Subjects With Mild, Moderate Hepatic Impairment Compared to the Control Subjects With Normal Hepatic Function
This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild or moderate hepatic impairment (HI) compared to the matched control subjects with normal hepatic function.
Read the detailed description
DBPR108 is a potent dipeptidylpeptidase-4 inhibitor. The aim of this study is to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild or moderate hepatic impairment (HI) compared to the matched control subjects with normal hepatic function. This study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period (Day 1 to Day 3), and a follow-up call on Day 6.
Subjects will be enrolled in the following groups:
(A) mild hepatic impairment (Child-Pugh class A, 5-6 points); (B) moderate hepatic impairment (Child-Pugh class B, 7-9 points); (C) control subjects with normal hepatic function will be matched with subjects with HI by weight, age, and sex.
Approximately 8 subjects will be enrolled in each group.
- Conditions
- Hepatic Impairment
- Being tested
- DBPR108 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBPR108 tabletsDrug
Also called DBPR108
Drug: DBPR108, tablet, oral
| Study group | Role | What they receive |
|---|---|---|
| Mild Hepatic Impairment | Experimental | Subjects will receive a single dose of 100 mg DBPR108. Receives: Drug: DBPR108 tablets |
| Moderate Hepatic Impairment | Experimental | Subjects will receive a single dose of 100 mg DBPR108. Receives: Drug: DBPR108 tablets |
| Normal hepatic function | Experimental | Subjects will receive a single dose of 100 mg DBPR108. Receives: Drug: DBPR108 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pharmacokinetic parameters of DBPR108
Cmax
Measured: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The pharmacokinetic parameters of DBPR108
AUC0-t
Measured: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The pharmacokinetic parameters of DBPR108
AUC0-inf
Measured: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
Secondary outcomes (5)
The pharmacokinetic parameters of DBPR108
Tmax
Measured: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The pharmacokinetic parameters of DBPR108
t1/2
Measured: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The pharmacokinetic parameters of DBPR108
Vz/F
Measured: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The pharmacokinetic parameters of DBPR108
CL/F
Measured: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The number of volunteers with adverse events as a measure of safety and tolerability
The number of volunteers with adverse events as a measure of safety and tolerability
Measured: Day 1 to Day6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start9 Jun 2021
- Primary completion14 May 2022
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859426
- Sponsor's protocol ID
- HA1118-CSP-008
- Status last verified
- Apr 2023
- First submitted
- 21 Apr 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Phase I Study to Assess the Pharmacokinetics and Safety of DBPR108 Tablets in Subjects With Mild, Moderate Hepatic Impairment Compared to the Control Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT04859426
- Acronym / sponsor ID
- HA1118-CSP-008
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 14 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 26 Apr 2021 (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.
This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild or moderate hepatic impairment (HI) compared to the matched control subjects with normal hepatic function.
Detailed description
DBPR108 is a potent dipeptidylpeptidase-4 inhibitor. The aim of this study is to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild or moderate hepatic impairment (HI) compared to the matched control subjects with normal hepatic function. This study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period (Day 1 to Day 3), and a follow-up call on Day 6.
Subjects will be enrolled in the following groups:
(A) mild hepatic impairment (Child-Pugh class A, 5-6 points); (B) moderate hepatic impairment (Child-Pugh class B, 7-9 points); (C) control subjects with normal hepatic function will be matched with subjects with HI by weight, age, and sex.
Approximately 8 subjects will be enrolled in each group.
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 Impairment | Experimental | Drug: DBPR108 tabletsSubjects will receive a single dose of 100 mg DBPR108. |
| Moderate Hepatic Impairment | Experimental | Drug: DBPR108 tabletsSubjects will receive a single dose of 100 mg DBPR108. |
| Normal hepatic function | Experimental | Drug: DBPR108 tabletsSubjects will receive a single dose of 100 mg DBPR108. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions；
- 18 years to 79 years (inclusive), male or female；
- Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Body mass index (BMI) : 18-30 kg/m2 (inclusive) (BMI= weight (kg)/height 2 (m2))；
- Subjects (including partners) are willing to use effective contraceptives from screening to the 6 months after the last dose administration；
- Medically stable hepatic impairment on the Child-Pugh Class A (mild) or Child-Pugh Class B (moderate) caused by a primary hepatic disease;
Key exclusion criteria (23 listed)
- Subjects who have a history of allergic conditions (such as asthma, urticaria), or have a history of allergy to two or more drugs or food, or may be allergic to the test drug and the related compounds;
- Have a history of severe and uncontrolled diseases, such as cardiovascular, respiratory, gastrointestinal, endocrine, hematologic, mental/nervous systems diseases within one year prior to screening；
- Subjects who have previously undergone surgery that may affect drug absorption, distribution, metabolism, or excretion (e.g., subtotal gastrectomy), or who have a scheduled surgical plan during the study period;
- Use of any DPP-IV enzyme inhibitor within 2 weeks prior to the screening;
- Drug abuse, or positive urine drug screen at screening；
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 |
|---|---|---|
| DBPR108 tabletsAlso: DBPR108Drug: DBPR108, tablet, oral | Drug | Mild Hepatic Impairment, Moderate Hepatic Impairment, Normal hepatic function |
Primary outcome
The pharmacokinetic parameters of DBPR108
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
Cmax
The pharmacokinetic parameters of DBPR108
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
AUC0-t
The pharmacokinetic parameters of DBPR108
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
AUC0-inf
5 secondary outcomes
The pharmacokinetic parameters of DBPR108
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The pharmacokinetic parameters of DBPR108
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The pharmacokinetic parameters of DBPR108
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The pharmacokinetic parameters of DBPR108
Time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: Day 1 to Day6
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 12 Apr 2023.
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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 DBPR108 tablets in people with Hepatic Impairment, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. 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 12 inclusion and 23 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 12 Apr 2023. 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 pharmacokinetic parameters of DBPR108 (time frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, and 48 hours after dosing). 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 12 Apr 2023.