PharmacokineticPhase 1NCT06126562
A Pharmacokinetic Study of Lanifibranor in Healthy Adult Chinese Subjects
A Phase 1 study testing Lanifibranor in people with Pharmacokinetic, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This will be a randomized, open-label parallel design and single centre study conducted at the 1st hospital affiliated to Jilin University. Approximately 24 healthy Chinese volunteers, male and female will be recruited and divided into two equal groups (12 subjects per dose). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic
- What is being tested?
- Lanifibranor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2023to 15 Dec 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-45 years (both inclusive) at the time of signing the informed consent form (ICF), regardless of gender;
- Male subjects body weight ≥ 50 kg and female subjects body weight ≥ 45 kg, with a body mass index (BMI) of 18-28 kg/m2 (both inclusive);
- No clinically significant findings in medical history, physical examination, 12-lead ECG, vital signs, laboratory tests, etc.;
- Normal clinical laboratory test values at screening and baseline (Day 1) or judged as not clinically significant by the investigator and/or sponsor;
- Alanine aminotransferase ≤ 1.1 × upper limit of normal (ULN), aspartate aminotransferase ≤ 1.2 × ULN; normal renal function, estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m2 at screening.
- Subjects need to understood the study, agree to voluntarily participate in the study, to comply with the study requirements, and provide written informed consent;
- Female subjects of childbearing potential must agree to use 2 highly effective methods of contraception, barrier contraception, during the study and within 30 days after one of which must be the study treatment. Female subjects must have a negative serum pregnancy test at screening and baseline (Day 1).
- Male subjects and their female partners of childbearing potential must agree to use 2 highly effective methods of contraception (as defined above), one of which must be a barrier method, during the study and for 90 days after receiving the study drug.
Who cannot join
- History or evidence of respiratory, circulatory, endocrine, urinary, digestive, immunological, reproductive, hematological, neurological, or psychiatric disorders, especially any history that may affect drug absorption, distribution, metabolism, and excretion.
- Subjects who are positive for any of the following: hepatitis B virus surface antigen (HBs-Ag), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV), and treponema pallidum antibody (anti-TP).
- Subjects with any of the following conditions within 6 months prior to screening: Unstable body weight, Women with irregular menstruation or ovulation, including but not limited to women with Stein-Leventhal syndrome and perimenopausal women with abnormal ovulation, History of osteoporosis or fracture, History of oedema peripheral at any site, History of gallbladder disease, including but not limited to cholelithiasis, and cholecystitis, History of hypoglycemia or events highly suspicious of hypoglycaemia.
- Current tissue dysplasia or history of malignancy (including lymphoma and leukemia) within the past 5 years, except for successfully cured non-metastatic basal cell carcinoma or squamous cell carcinoma or localized cervical carcinoma in situ.
- Pregnant, lactating women, or women planning to become pregnant during the study or within 30 days of study drug administration.
- Treatment with another study drug or device within 3 months before study drug administration; or less than 5 half-lives from treatment with another study drug or device at screening, whichever is longer.
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- Known hypersensitivity or intolerance to lanifibranor or any of the excipients, and allergic constitution.
- Consumption of more than 28 units of ethanol per week, or a history of alcohol abuse, at any time within 6 months prior to study drug administration.
- Smoking more than 5 cigarettes per day or consuming an equivalent amount of nicotine or nicotine-containing products within 6 months before screening, or an inability to discontinue the use of any tobacco products during the study.
- Taking prescription drugs (excluding oral and other contraceptives [e.g., long-acting formulations, transdermal contraceptives, and intrauterine devices]), including nonsteroidal anti-inflammatory drugs, sucralfate, drugs known to decrease metabolism or increase bioavailability, traditional Chinese medicine preparations, melatonin, or other nutritional supplements, within 14 days or 5 half-lives (whichever is longer) before study drug administration, or taking over-the-counter drugs, vitamins, or supplements (including cod-liver oil) within 7 days before study drug administration.
- Consuming products containing alcohol, caffeine, or xanthines, Seville oranges, and grapefruit or grapefruit juice within 72 hours prior to study drug administration.
- Engagement in strenuous activity (e.g., exercise) within 96 h (4 days) before admission to the clinical research unit (CRU) and throughout the study.
- Donation of more than 500 mL of blood or significant blood loss within 90 days prior to admission to the CRU.
- History or evidence of poor venous access or hemorrhagic disorder.
- History of drug use, drug abuse, or positive urine drug test.
- Any condition that, as determined by the investigator, may pose a safety risk to the subject during the study or may interfere with the study's conduct, or the investigator believes that the subject may not be able to complete the study or comply with its requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Study to Evaluate the Pharmacokinetic Profile and Safety of Lanifibranor After Single Dose and Multiple Doses in Healthy Adult Chinese Subjects
This will be a randomized, open-label parallel design and single centre study conducted at the 1st hospital affiliated to Jilin University. Approximately 24 healthy Chinese volunteers, male and female will be recruited and divided into two equal groups (12 subjects per dose). The primary objective of this study is to evaluate the pharmacokinetic profile of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects. The secondary objective is to evaluate the safety of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects.
- Conditions
- Pharmacokinetic
- Being tested
- Lanifibranor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LanifibranorDrug
Lanifibranor is a pan-peroxisome proliferator-activated receptor (PPAR) agonist.
| Study group | Role | What they receive |
|---|---|---|
| Lanifibranor 800 mg | Experimental | In Part A, lanifibranor 800 mg is given as a single dose (followed by 14 days follow-up).
In Part B, lanifibranor 800 mg is given once daily for 7 consecutive days (followed by 7 days follow-up). Receives: Drug: Lanifibranor |
| Lanifibranor 120 mg | Experimental | In Part A, lanifibranor 1200 mg is given as a single dose (followed by 14 days follow-up).
In Part B, lanifibranor 1200 mg is given once daily for 7 consecutive days (followed by 7 days follow-up). Receives: Drug: Lanifibranor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)
Maximum plasma drug concentration
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Area under the plasma concentration-time curve
The area enclosed by the blood concentration curve to the timeline
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Time to maximum concentration (Tmax)
The time required to reach peak concentration after administration
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Apparent volume of distribution (Vd/F)
Drug dose reach a dynamic balance in the body the body and blood drug concentration ratio constant
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Apparent plasma clearance (CL/F)
The volume of plasma with drug cleared per unit of time
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Plasma elimination half-life (t1/2)
The time it takes for the terminal phase blood concentration to drop by half
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Time to maximum concentration at steady state (Tmax, ss) in Part B
The time required to reach peak steady-state concentration after administration
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Maximum concentration at steady state (Cmax, ss) in Part B
The maximum blood drug concentration that occurs after stabilization
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Minimum concentration at steady state (Cmin, ss) in Part B
The minimum blood drug concentration that occurs after stabilization
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Average steady-state plasma concentration (Cav, ss) in Part B
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Secondary outcomes (2)
Adverse event rate
The occurrence rate of all adverse events (AEs), and adverse events of special interest (AESI) and serious adverse events (SAEs).
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Adverse event rate
The occurrence rate of abnormal clinical laboratory tests, vital signs, physical examination and 12 lead-electrocardiogram (ECG).
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start31 Oct 2023
- Primary completion28 Nov 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126562
- Sponsor's protocol ID
- LNLN-I-01
- Status last verified
- Dec 2023
- First submitted
- 7 Nov 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Pharmacokinetic Profile and Safety of Lanifibranor After Single Dose and Multiple Doses in Healthy Adult Chinese Subjects
- ClinicalTrials.gov ID
- NCT06126562
- Acronym / sponsor ID
- LNLN-I-01
- Conditions
- Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 13 Nov 2023 (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 will be a randomized, open-label parallel design and single centre study conducted at the 1st hospital affiliated to Jilin University. Approximately 24 healthy Chinese volunteers, male and female will be recruited and divided into two equal groups (12 subjects per dose). The primary objective of this study is to evaluate the pharmacokinetic profile of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects. The secondary objective is to evaluate the safety of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lanifibranor 800 mg | Experimental | Drug: LanifibranorIn Part A, lanifibranor 800 mg is given as a single dose (followed by 14 days follow-up). In Part B, lanifibranor 800 mg is given once daily for 7 consecutive days (followed by 7 days follow-up). |
| Lanifibranor 120 mg | Experimental | Drug: LanifibranorIn Part A, lanifibranor 1200 mg is given as a single dose (followed by 14 days follow-up). In Part B, lanifibranor 1200 mg is given once daily for 7 consecutive days (followed by 7 days follow-up). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Aged 18-45 years (both inclusive) at the time of signing the informed consent form (ICF), regardless of gender;
- Male subjects body weight ≥ 50 kg and female subjects body weight ≥ 45 kg, with a body mass index (BMI) of 18-28 kg/m2 (both inclusive);
- No clinically significant findings in medical history, physical examination, 12-lead ECG, vital signs, laboratory tests, etc.;
- Normal clinical laboratory test values at screening and baseline (Day 1) or judged as not clinically significant by the investigator and/or sponsor;
- Alanine aminotransferase ≤ 1.1 × upper limit of normal (ULN), aspartate aminotransferase ≤ 1.2 × ULN; normal renal function, estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m2 at screening.
Key exclusion criteria (16 listed)
- History or evidence of respiratory, circulatory, endocrine, urinary, digestive, immunological, reproductive, hematological, neurological, or psychiatric disorders, especially any history that may affect drug absorption, distribution, metabolism, and excretion.
- Subjects who are positive for any of the following: hepatitis B virus surface antigen (HBs-Ag), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV), and treponema pallidum antibody (anti-TP).
- Subjects with any of the following conditions within 6 months prior to screening: Unstable body weight, Women with irregular menstruation or ovulation, including but not limited to women with Stein-Leventhal syndrome and perimenopausal women with abnormal ovulation, History of osteoporosis or fracture, History of oedema peripheral at any site, History of gallbladder disease, including but not limited to cholelithiasis, and cholecystitis, History of hypoglycemia or events highly suspicious of hypoglycaemia.
- Current tissue dysplasia or history of malignancy (including lymphoma and leukemia) within the past 5 years, except for successfully cured non-metastatic basal cell carcinoma or squamous cell carcinoma or localized cervical carcinoma in situ.
- Pregnant, lactating women, or women planning to become pregnant during the study or within 30 days of study drug administration.
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 |
|---|---|---|
| LanifibranorLanifibranor is a pan-peroxisome proliferator-activated receptor (PPAR) agonist. | Drug | Lanifibranor 120 mg, Lanifibranor 800 mg |
Primary outcome
Maximum concentration (Cmax)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Maximum plasma drug concentration
Area under the plasma concentration-time curve
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
The area enclosed by the blood concentration curve to the timeline
Time to maximum concentration (Tmax)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
The time required to reach peak concentration after administration
Apparent volume of distribution (Vd/F)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Drug dose reach a dynamic balance in the body the body and blood drug concentration ratio constant
Apparent plasma clearance (CL/F)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
The volume of plasma with drug cleared per unit of time
Plasma elimination half-life (t1/2)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
The time it takes for the terminal phase blood concentration to drop by half
Time to maximum concentration at steady state (Tmax, ss) in Part B
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
The time required to reach peak steady-state concentration after administration
Maximum concentration at steady state (Cmax, ss) in Part B
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
The maximum blood drug concentration that occurs after stabilization
Minimum concentration at steady state (Cmin, ss) in Part B
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
The minimum blood drug concentration that occurs after stabilization
Average steady-state plasma concentration (Cav, ss) in Part B
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
The plasma concentration at which the rate of administration and rate of elimination are in equilibrium.
2 secondary outcomes
Adverse event rate
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.
Adverse event rate
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after 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 2 Jan 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.
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 Lanifibranor in people with Pharmacokinetic, run by Chia Tai Tianqing Pharmaceutical Group 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 8 inclusion and 16 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 2 Jan 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?
Maximum concentration (Cmax) (time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, 120, 168 hours after dose.). The study lists 10 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 2 Jan 2024.