Hepatic ImpairmentPhase 1NCT05515445
Pharmacokinetics of Chiglitazar in Subjects With Hepatic Impairment and Normal Hepatic Function
A Phase 1 study testing Chiglitazar in people with Hepatic Impairment, run by Chipscreen Biosciences, Ltd. at 1 site in China.
Trial summary
This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of Chiglitazar following administration of a single oral dose in subjects with varying degrees of hepatic impairment compared to 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?
- Chiglitazar
- 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
- 3 Dec 2022to 23 Aug 2023
- 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
- Voluntarily sign informed consent, able to comply with the requirements of the study.
- Male or female, between 18 and 79 years of age.
- 18≤BMI≤30. Weight of male ≥50 kg and Weight of female ≥ 45 kg.
- No medication within 2 weeks, or stable medication for at least 4 weeks prior to screening.
- Physical examination, vital signs examination, 12-lead electrocardiogram (ECG) examination, and laboratory test have been determined by the investigator to be suitable for participating in this trial.
Who cannot join
- Allergic constitution, or allergic to PPAR agonist drugs or any component of Chiglitazar tablets.
- received PPAR agonist drugs within 2 weeks before screening.
- Those who have been vaccinated within 4 weeks before screening, or who plan to be vaccinated during the trial.
- positive test for COVID-19, TP antibody and RPR, or HIV antibody.
- suffer from uncontrolled serious diseases of cardiovascular, respiratory, gastrointestinal, endocrine, blood, mental/nervous systems within 1 year before screening.
- have previously undergone surgery that may affect the absorption, distribution, metabolism, and excretion of drugs; anticipate surgery or hospitalization during the trial.
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- Drug abusers, or positive test for drugs of abuse.
- Smoking more than 5 cigarettes per day on average within 3 months before screening.
- The average daily alcohol intake in the 3 months prior to screening exceeds the following criteria: more than 14 g for women, or more than 28 g for men; ingested any products containing alcohol within 48 hours before administration; positive alcohol breath test; patients with alcoholic cirrhosis who did not abstinence within 3 months before screening.
- Ingestion of grapefruit juice/grapefruit juice, food or drink rich in methylxanthine within 48 hours before administration; strenuous exercise or other factors that affect drug absorption, distribution, metabolism, excretion.
- participated in clinical trials of any drug or medical device within 3 months before screening.
- donated blood (or blood loss) ≥400 mL within 3 months before screening, or received whole blood or red blood cell suspension.
- Female subjects who are breastfeeding or positive test of serum pregnancy.
- eGFR<60 mL/min/1.73m2.
- Other circumstances assessed by the investigator are not suitable for participating in this trial.
- Supplementary exclusion criteria for subjects with hepatic impairment：
- drug-induced liver injury.
- acute liver function damage caused by various reasons;
- complications of liver cirrhosis that the investigator considers inappropriate to participate in the study.
- diseases that seriously affect bile excretion.
- Supplementary exclusion criteria for subjects with normal hepatic function:
- history of hepatic function damage, or who may have hepatic function damage that the investigator considers to be clinically significant.
- positive test for HBsAg, HCV.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Evaluate the Pharmacokinetics of Chiglitazar in Subjects With Hepatic Impairment and Normal Hepatic Function
This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of Chiglitazar following administration of a single oral dose in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function.
- Conditions
- Hepatic Impairment
- Being tested
- Chiglitazar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChiglitazarDrug
Oral single dose 48 mg
| Study group | Role | What they receive |
|---|---|---|
| Normal Hepatic Function | Experimental | Subjects with normal hepatic function will receive a single 48 mg oral dose of Chiglitazar Receives: Drug: Chiglitazar |
| Mild Hepatic Impairment | Experimental | Subjects with mild hepatic impairment will receive a single 48 mg oral dose of Chiglitazar Receives: Drug: Chiglitazar |
| Moderate Hepatic Impairment | Experimental | Subjects with moderate hepatic impairment will receive a single 48 mg oral dose of Chiglitazar Receives: Drug: Chiglitazar |
| Severe Hepatic Impairment | Experimental | Subjects with severe hepatic impairment will receive a single 48 mg oral dose of Chiglitazar Receives: Drug: Chiglitazar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration
Measured: 4 days
AUC0-t and AUC0-inf
Area under of the curve (AUC0-t and AUC0-inf)
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start3 Dec 2022
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
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 Chipscreen Biosciences, 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
- Chipscreen Biosciences, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- LiYan Miao, Principal investigator, First Affiliated Hospital of Suzhou Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515445
- Sponsor's protocol ID
- CGZ108
- Status last verified
- May 2024
- First submitted
- 23 Aug 2022
- Last updated
- 28 May 2024
- 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 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Pharmacokinetics of Chiglitazar in Subjects With Hepatic Impairment and Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT05515445
- Acronym / sponsor ID
- CGZ108
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2022 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 25 Aug 2022 (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 Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of Chiglitazar following administration of a single oral dose in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Hepatic Function | Experimental | Drug: ChiglitazarSubjects with normal hepatic function will receive a single 48 mg oral dose of Chiglitazar |
| Mild Hepatic Impairment | Experimental | Drug: ChiglitazarSubjects with mild hepatic impairment will receive a single 48 mg oral dose of Chiglitazar |
| Moderate Hepatic Impairment | Experimental | Drug: ChiglitazarSubjects with moderate hepatic impairment will receive a single 48 mg oral dose of Chiglitazar |
| Severe Hepatic Impairment | Experimental | Drug: ChiglitazarSubjects with severe hepatic impairment will receive a single 48 mg oral dose of Chiglitazar |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily sign informed consent, able to comply with the requirements of the study.
- Male or female, between 18 and 79 years of age.
- 18≤BMI≤30. Weight of male ≥50 kg and Weight of female ≥ 45 kg.
- No medication within 2 weeks, or stable medication for at least 4 weeks prior to screening.
- Physical examination, vital signs examination, 12-lead electrocardiogram (ECG) examination, and laboratory test have been determined by the investigator to be suitable for participating in this trial.
Key exclusion criteria (23 listed)
- Allergic constitution, or allergic to PPAR agonist drugs or any component of Chiglitazar tablets.
- received PPAR agonist drugs within 2 weeks before screening.
- Those who have been vaccinated within 4 weeks before screening, or who plan to be vaccinated during the trial.
- positive test for COVID-19, TP antibody and RPR, or HIV antibody.
- suffer from uncontrolled serious diseases of cardiovascular, respiratory, gastrointestinal, endocrine, blood, mental/nervous systems within 1 year before 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 |
|---|---|---|
| ChiglitazarOral single dose 48 mg | Drug | Mild Hepatic Impairment, Moderate Hepatic Impairment, Normal Hepatic Function, Severe Hepatic Impairment |
Primary outcome
Cmax
Time frame: 4 days
Maximum plasma concentration
AUC0-t and AUC0-inf
Time frame: 4 days
Area under of the curve (AUC0-t and AUC0-inf)
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 28 May 2024.
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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.
LiYan Miao principal investigator
First Affiliated Hospital of Suzhou Medical College
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 Chiglitazar in people with Hepatic Impairment, run by Chipscreen Biosciences, 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 5 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 28 May 2024. 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: 4 days). 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 28 May 2024.