Healthy Adult Male VolunteersPhase 1NCT05059743
ADME Study of [14C]- Larotinib in Healthy Male Subjects
A Phase 1 study testing [14C]-Larotinib in people with Healthy Adult Male Volunteers, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]-Larotinib（Z650）in healthy male 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
- Healthy Adult Male Volunteers
- What is being tested?
- [14C]-Larotinib
- 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
- 20 Nov 2021to 10 Jan 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males, 18 to 45 years at the time of screening.
- Weight>50 kg, Body mass index (BMI) is 19~26 kg/m2
- signing of informed consent
- Volunteers are able to communicate well with the investigators and be able to complete the trial according to the process
Who cannot join
- physical examination, vital signs, routine laboratory tests 12-lead ECG, Chest X-ray ,ophthalmologic examination, abdominal B-ultrasound and other abnormalities and clinical significance.
- positive testing for HIV, HBsAg, HBeAb, HCVAb or Syphilis antibody.
- C- reactive protein (CRP) abnormalities are clinically significant or New Coronavirus nucleic acid positive.
- Screening for use of any clinical trial drug within the first 3 months or withdrawal time shorter than the 7 half-life period of the trial drug at enrollment, whichever is the longest of the two;
- CYP3A4, CYP2C8 , CYP2C9 and p-gp inducers or inhibitors were taken within 28 days before screening
- Use of any prescription or over-the-counter drug, any vitamin product, health care drug or Chinese herbal medicine within 14 days prior to screening;
Show all 24Show fewer
- clinical symptoms or diseases of the heart;supraventral or ventricular arrhythmia with clinical significance that requires treatment or intervention; QTcF>450ms at screening stage
- Patients who had undergone major surgery or whose surgical incision was not completely healed within 6 months before the screening period;Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, prolonged general anesthesia, or an open biopsy or significant traumatic injury;
- Significant clinical bleeding symptoms or definite bleeding tendency occurred within 3 months before screening
- Screening for abdominal fistula, gastrointestinal perforation or abdominal abscess in the first 6 months;
- Hemorrhoids or perianal diseases with regular/bleeding in the stool;Patients with gastrointestinal dysfunction, such as irritable bowel syndrome and inflammatory bowel disease, may be affected by drug absorption as determined by researchers;
- Allergic persons,
- A history of any clinically serious illness or condition, including but not limited to circulatory, endocrine, nervous, digestive, urinary, or blood, immune, mental, and metabolic diseases, that the investigator considers to be likely to affect the results of the study;
- Habitual constipation or diarrhea;
- Heavy drinking or regular drinking in the six months preceding the screening period
- Those who had smoked more than 5 cigarettes per day on average in the 3 months before the screening period or habitually used nicotine-containing products and were unable to quit during the test period;
- Substance abuse or use of soft drugs (e.g., marijuana) in the 3 months prior to the screening period or use of hard drugs (e.g., cocaine, amphetamines, phenylcyclohexidine, etc.) in the 1 year prior to the screening period;Or screening for positive urine drug abuse (drug) tests;
- habitual consumption of grapefruit juice or excessive consumption of tea, coffee and/or caffeinated beverages and failure to abstain during the study period;
- Those with a history of fainting needle or blood, have difficulty in blood collection or cannot tolerate vein puncture for blood collection;
- Workers engaged in conditions requiring long-term exposure to radioactivity;Or have significant radiation exposure (≥2 chest/abdomen CT, or ≥3 other types of X-ray examinations) within 1 year before the test or have participated in the radiopharmaceutical labeling test;
- Those who have lost blood or donated up to 400 mL within 3 months before the screening period, or those who have received blood transfusion, or those who plan to donate blood within 3 month after the end of this test;
- Those who have been vaccinated within 1 month before screening or those who plan to be vaccinated during the trial period;
- Having family planning during the trial period and within 12 months after the last use of the drug, or not agreeing that subjects and their spouses should take strict contraceptive measures during the trial period and within 12 months after the last use of the drug;
- As determined by the investigator, the subject has other factors that are not suitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C] - Larotinib in Healthy Male Participants
Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]-Larotinib（Z650）in healthy male subjects.
- Conditions
- Healthy Adult Male Volunteers
- Being tested
- [14C]-Larotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-LarotinibDrug
Patients will receive single dose of orally [14C]-Larotinib on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| [14C]-Larotinib | Experimental | Patients will receive single dose of [14C]-Larotinib (Suspension, 350mg/100μCi). Receives: Drug: [14C]-Larotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative excretion of 14C-labeled drug-related material (radioactivity in plasma, urine and fecal samples)
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.
Measured: up to 15 days
Identification of the Proportion of different metabolites to determine biotransformation pathway of Larotinib
Proportion of different metabolites(Larotinib and main metabolites） .
Measured: up to 15 days
Secondary outcomes (2)
Quantitive analysis of the concentrations of Larotinib in plasma using the validated LC-MS/MS to obtain pharmacokinetic data
The concentrations of Larotinib in plasma
Measured: up to 15 days
Adverse events
Adverse events assessed by CTCAE v5.0.
Measured: up to 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start20 Nov 2021
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Male VolunteersStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., 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
- NCT05059743
- Sponsor's protocol ID
- Z650-HV-106
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 21 Mar 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 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C] - Larotinib in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT05059743
- Acronym / sponsor ID
- Z650-HV-106
- Conditions
- Healthy Adult Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 28 Sep 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.
Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]-Larotinib（Z650）in healthy male subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-Larotinib | Experimental | Drug: [14C]-LarotinibPatients will receive single dose of [14C]-Larotinib (Suspension, 350mg/100μCi). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males, 18 to 45 years at the time of screening.
- Weight>50 kg, Body mass index (BMI) is 19~26 kg/m2
- signing of informed consent
- Volunteers are able to communicate well with the investigators and be able to complete the trial according to the process
Key exclusion criteria (24 listed)
- physical examination, vital signs, routine laboratory tests 12-lead ECG, Chest X-ray ,ophthalmologic examination, abdominal B-ultrasound and other abnormalities and clinical significance.
- positive testing for HIV, HBsAg, HBeAb, HCVAb or Syphilis antibody.
- C- reactive protein (CRP) abnormalities are clinically significant or New Coronavirus nucleic acid positive.
- Screening for use of any clinical trial drug within the first 3 months or withdrawal time shorter than the 7 half-life period of the trial drug at enrollment, whichever is the longest of the two;
- CYP3A4, CYP2C8 , CYP2C9 and p-gp inducers or inhibitors were taken within 28 days 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 |
|---|---|---|
| [14C]-LarotinibPatients will receive single dose of orally [14C]-Larotinib on Day 1. | Drug | [14C]-Larotinib |
Primary outcome
Cumulative excretion of 14C-labeled drug-related material (radioactivity in plasma, urine and fecal samples)
Time frame: up to 15 days
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.
Identification of the Proportion of different metabolites to determine biotransformation pathway of Larotinib
Time frame: up to 15 days
Proportion of different metabolites(Larotinib and main metabolites） .
2 secondary outcomes
Quantitive analysis of the concentrations of Larotinib in plasma using the validated LC-MS/MS to obtain pharmacokinetic data
Time frame: up to 15 days
Adverse events
Time frame: up to 22 days
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 21 Mar 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.
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]-Larotinib in people with Healthy Adult Male Volunteers, run by Sunshine Lake Pharma 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 4 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 21 Mar 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?
Cumulative excretion of 14C-labeled drug-related material (radioactivity in plasma, urine and fecal samples) (time frame: up to 15 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 21 Mar 2023.