Clinical PharmacologyPhase 1NCT06126861
The Mass Balance Study of LP-168 in Healthy Subjects
A Phase 1 study testing [14C]LP-168 in people with Clinical Pharmacology, run by Guangzhou Lupeng Pharmaceutical Company LTD. at 1 site in China.
Trial summary
This study is a single-center, open-label, single-dose clinical pharmacokinetic study. The purpose of this study is to investigate the absorption characteristics, as well as to evaluate the metabolism and elimination pathways after a single oral dose of 150mg, 100μCi [14C]LP-168 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Clinical Pharmacology
- What is being tested?
- [14C]LP-168
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2023to 13 Mar 2024
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects
- Aged 18-45 (including the boundary value);
- Body weight over 50 kg, the body mass index (BMI) is between 19 and 26 kg/m2 (including the boundary value);
- Subjects must sign the informed consent form voluntarily;
- Agree to abide the requirements of the study protocol, willing to communicate with the study doctor.
Who cannot join
- After a comprehensive physical examination, vital signs, laboratory tests and other examinations are abnormal and have clinical significance;
- Hepatitis B surface antigen or E antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), human immunodeficiency virus antigen/antibody combined test (HIV-Ag/Ab) and Treponema pallidum antibody test positive;
- Subject with clinically significant abnormalities on ophthalmologic examination (slit lamp, intraocular pressure and fundus photography)
- Subject who have used any drug that inhibits or induces hepatic drug metabolizing enzymes or transporters during the screening period and within the previous 28 days;
- Subject who have taken any medication with inhibition gastric acid secretion during the screening period and within the previous 28 days
- Subject who have taken any anti-gastric acid medication during the screening period and within the previous 28 days
Show all 24Show fewer
- Subject who have used any systemic medication during the screening period and within the previous 14 days
- Subject with a history of any clinically serious illness or disease or condition that, in the opinion of the investigator, may affect the results of the trial
- Subject with any condition that may affect the absorption of the drug
- Subject with history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, ventricular tachycardia, atrioventricular block, QT prolongation syndrome, or symptoms of QT prolongation syndrome or family history of these syndrome.
- Subject with major surgery during the screening period and within the previous 6 months or surgical incisions that have not fully healed
- Subject with allergies, such as a known history of allergy to two or more substances
- Subject with hemorrhoids or perianal disease with regular or ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease
- Subject with habitual constipation or diarrhea
- Subject with alcohol abuse or regular use of alcohol in the 6 months prior to the screening period
- Subject with smoking >5 cigarettes per day before the first 3 months of the screening period
- Subject with drug abuse
- Subject who are subjected to long-term exposure to radioactive conditions
- Subject who have difficulty collecting blood or cannot tolerate venipuncture for blood collection
- Subject with participation in any other clinical trial during the screening period and within the previous 3 months
- Subject who have been vaccinated during the screening period and within the previous 1 month or who are scheduled to be vaccinated during the trial period
- Subject with plans to have children or donate sperm during the trial and within 1 year after completion of the trial
- Subject who had lost or donated up to 400 mL of blood during the screening period and within the previous 3 months, or those who had received a blood transfusion within 1 month;
- Subject with any factors that the investigator believes make participation in this trial inappropriate
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: The Mass Balance Study of [14C]LP-168 in Chinese Healthy Subjects
This study is a single-center, open-label, single-dose clinical pharmacokinetic study. The purpose of this study is to investigate the absorption characteristics, as well as to evaluate the metabolism and elimination pathways after a single oral dose of 150mg, 100μCi [14C]LP-168 in healthy subjects.
- Conditions
- Clinical Pharmacology
- Being tested
- [14C]LP-168
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]LP-168Drug
single dose of 150 mg/100 μCi [14C] LP-168, orally suspension at fasted state
| Study group | Role | What they receive |
|---|---|---|
| [14C]LP-168 | Experimental | Using 14C-labeled LP-168 as a marker to investigate the absorption characteristic, as well as to evaluate the metabolism and elimination pathways in healthy subjects Receives: Drug: [14C]LP-168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radioactivity concentration of blood and plasma sample
Use liquid scintillation counter to evaluate Radioactivity concentration of each sample
Measured: Day 1- Day 8
Radioactivity concentration of urine and feces sample
Use liquid scintillation counter to evaluate Radioactivity concentration of each sample
Measured: Day 1- Day 15
Number of metabolites and its proportion in plasma, urine and feces.
To study the metabolite profiling
Measured: Day 1- Day 15
Secondary outcomes (2)
Plasma LP-168/Major Metabolic concentrations
To determine the plasma concentrations of LP-168/Major Metabolic using LC-MS/MS.
Measured: Day 1- Day 8
Treatment emergent adverse events as assessed by CTCAE 5.0
To evaluate the safety after the study intervention
Measured: Day 1- Day 15
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 start25 Dec 2023
- Primary completion2 Feb 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PharmacologyStudies of the same condition, open and under way.
- More trials run by Guangzhou Lupeng Pharmaceutical Company 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liyan Miao, MD, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126861
- Sponsor's protocol ID
- LP-168-CN104
- Status last verified
- Feb 2024
- First submitted
- 7 Nov 2023
- Last updated
- 15 Mar 2024
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mass Balance Study of [14C]LP-168 in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT06126861
- Acronym / sponsor ID
- LP-168-CN104
- Conditions
- Clinical Pharmacology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.Industry (pharma, biotech, devices)
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 13 Mar 2024 (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 study is a single-center, open-label, single-dose clinical pharmacokinetic study. The purpose of this study is to investigate the absorption characteristics, as well as to evaluate the metabolism and elimination pathways after a single oral dose of 150mg, 100μCi [14C]LP-168 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]LP-168 | Experimental | Drug: [14C]LP-168Using 14C-labeled LP-168 as a marker to investigate the absorption characteristic, as well as to evaluate the metabolism and elimination pathways in healthy subjects |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects
- Aged 18-45 (including the boundary value);
- Body weight over 50 kg, the body mass index (BMI) is between 19 and 26 kg/m2 (including the boundary value);
- Subjects must sign the informed consent form voluntarily;
- Agree to abide the requirements of the study protocol, willing to communicate with the study doctor.
Key exclusion criteria (24 listed)
- After a comprehensive physical examination, vital signs, laboratory tests and other examinations are abnormal and have clinical significance;
- Hepatitis B surface antigen or E antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), human immunodeficiency virus antigen/antibody combined test (HIV-Ag/Ab) and Treponema pallidum antibody test positive;
- Subject with clinically significant abnormalities on ophthalmologic examination (slit lamp, intraocular pressure and fundus photography)
- Subject who have used any drug that inhibits or induces hepatic drug metabolizing enzymes or transporters during the screening period and within the previous 28 days;
- Subject who have taken any medication with inhibition gastric acid secretion during the screening period and within the previous 28 days
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 |
|---|---|---|
| [14C]LP-168single dose of 150 mg/100 μCi [14C] LP-168, orally suspension at fasted state | Drug | [14C]LP-168 |
Primary outcome
Radioactivity concentration of blood and plasma sample
Time frame: Day 1- Day 8
Use liquid scintillation counter to evaluate Radioactivity concentration of each sample
Radioactivity concentration of urine and feces sample
Time frame: Day 1- Day 15
Use liquid scintillation counter to evaluate Radioactivity concentration of each sample
Number of metabolites and its proportion in plasma, urine and feces.
Time frame: Day 1- Day 15
To study the metabolite profiling
2 secondary outcomes
Plasma LP-168/Major Metabolic concentrations
Time frame: Day 1- Day 8
Treatment emergent adverse events as assessed by CTCAE 5.0
Time frame: Day 1- Day 15
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 15 Mar 2024.
- 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.
Liyan Miao, MD principal investigator
The First Affiliated Hospital of Soochow University
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 [14C]LP-168 in people with Clinical Pharmacology, run by Guangzhou Lupeng Pharmaceutical Company 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 24 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 15 Mar 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?
Radioactivity concentration of blood and plasma sample (time frame: Day 1- Day 8). 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 15 Mar 2024.