Healthy Adult Male VolunteersPhase 1NCT05150717
ADME Study of [14C]-Jaktinib in Healthy Male Subjects
A Phase 1 study testing [14C]-Jaktinib in people with Healthy Adult Male Volunteers, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]-Jaktinib orally in Chinese 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]-Jaktinib
- 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
- 4 Jan 2022to 30 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 Chinese males, aged 18-45 years old (inclusive);
- Body weight ≥ 50.0 kg, body mass index (BMI) between 19-26kg/m2 (inclusive);
- Sign the informed consent form；
- Participants 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, abdominal B-ultrasound and other is abnormal and clinically significant;
- Positive for hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibodies;
- 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.
- Participants who have participated in any clinical trials within 3 months prior to screening and have used the test drug or medical devices.
- 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.
- Participants who had heart disease such as heart failure, angina pectoris, myocardial infarction, and clinically significant arrhythmia.
Show all 19Show fewer
- Participants 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.
- Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before screening.
- 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.
- Habitual constipation or diarrhea.
- Heavy drinking or regular drinking in the six months preceding the screening period, or alcohol breath test results ≥20 mg/dL during the screening period.
- Participants 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.
- Participants 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 inthe radiopharmaceutical labeling test.
- Having family planning during the trial period and within 1 year 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 1 year after the last use of the drug.
- Participants who had lost blood or donated up to 400mL within 3 months before the screening period, or Participants who had received blood transfusion, or Participants who plan to donate blood within 3 month after the end of this test.
- 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: Absorption, Distribution, Metabolism, and Excretion Study of [14C]-Jaktinib in Chinese Male Healthy Subjects(The Mass Balance and Biotransformation Study of [14C]-Jaktinib).
This study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]-Jaktinib orally in Chinese healthy male subjects.
- Conditions
- Healthy Adult Male Volunteers
- Being tested
- [14C]-Jaktinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-JaktinibDrug
Subjects will receive single dose of orally [14C]-Jaktinib on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| [14C]-Jaktinib | Experimental | Subjects will receive single dose of [14C]-Jaktinib (Suspension, 100mg/150μCi) Receives: Drug: [14C]-Jaktinib |
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 urine and fecal samples)
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in urine and feces.
Measured: From the start of administration to 240 hours after administration
Identification of the Proportion of different metabolites to determine biotransformation pathway of Jaktinib
Proportion of different metabolites(Jaktinib and main metabolites)
Measured: From the start of administration to 240 hours after administration
Secondary outcomes (2)
Quantitive analysis of the concentrations of Jaktinib and main metabolites in plasma to obtain pharmacokinetic data
The concentrations of Jaktinib and main metabolites in plasma
Measured: From the start of administration to 240 hours after administration
Adverse events
Adverse events assessed by CTCAE v5.0.
Measured: From the start of administration to 17days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start4 Jan 2022
- Primary completion30 Jan 2022
- Study completion30 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 Suzhou Zelgen Biopharmaceuticals Co.,LtdThe 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
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- liyan Miao, PhD, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150717
- Sponsor's protocol ID
- ZGJAK023
- Status last verified
- Jan 2024
- First submitted
- 24 Nov 2021
- Last updated
- 11 Jan 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 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption, Distribution, Metabolism, and Excretion Study of [14C]-Jaktinib in Chinese Male Healthy Subjects(The Mass Balance and Biotransformation Study of [14C]-Jaktinib).
- ClinicalTrials.gov ID
- NCT05150717
- Acronym / sponsor ID
- ZGJAK023
- Conditions
- Healthy Adult Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 9 Dec 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 study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]-Jaktinib orally in Chinese healthy male 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]-Jaktinib | Experimental | Drug: [14C]-JaktinibSubjects will receive single dose of [14C]-Jaktinib (Suspension, 100mg/150μCi) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Chinese males, aged 18-45 years old (inclusive);
- Body weight ≥ 50.0 kg, body mass index (BMI) between 19-26kg/m2 (inclusive);
- Sign the informed consent form；
- Participants are able to communicate well with the investigators and be able to complete the trial according to the Process.
Key exclusion criteria (19 listed)
- Physical examination, vital signs, routine laboratory tests, 12-lead ECG, Chest X-ray, abdominal B-ultrasound and other is abnormal and clinically significant;
- Positive for hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibodies;
- 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.
- Participants who have participated in any clinical trials within 3 months prior to screening and have used the test drug or medical devices.
- 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.
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]-JaktinibSubjects will receive single dose of orally [14C]-Jaktinib on Day 1. | Drug | [14C]-Jaktinib |
Primary outcome
Cumulative excretion of 14C-labeled drug-related material (radioactivity in urine and fecal samples)
Time frame: From the start of administration to 240 hours after administration
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in urine and feces.
Identification of the Proportion of different metabolites to determine biotransformation pathway of Jaktinib
Time frame: From the start of administration to 240 hours after administration
Proportion of different metabolites(Jaktinib and main metabolites)
2 secondary outcomes
Quantitive analysis of the concentrations of Jaktinib and main metabolites in plasma to obtain pharmacokinetic data
Time frame: From the start of administration to 240 hours after administration
Adverse events
Time frame: From the start of administration to 17days after administration
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 11 Jan 2024.
Related trials for Healthy Adult Male Volunteers
RecruitingPhase 1/2
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
Androgenetic Alopecia (AGA), Healthy Volunteers - Male and Female
RecruitingPhase 1
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
Renal Impairment, Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn About the Safety of BIIB115 Injections and How BIIB115 is Processed in the Bodies of Healthy Adult Male Volunteers and of Pediatric Participants With Spinal Muscular Atrophy Who Previously Took Onasemnogene Abeparvovec
Healthy Volunteer, Muscular Atrophy, Spinal
Recruiting
Nicotinamide Mononucleotide Supplementation for Exercise Tolerance Improvement in Healthy Older Adults
Aging, Frailty
Not yet recruitingPhase 1
Tegoprazan-Aspirin Drug Interaction in Healthy Adult Male Volunteers
Healthy Adult Male
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, PhD 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]-Jaktinib in people with Healthy Adult Male Volunteers, run by Suzhou Zelgen Biopharmaceuticals 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 19 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 11 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?
Cumulative excretion of 14C-labeled drug-related material (radioactivity in urine and fecal samples) (time frame: From the start of administration to 240 hours after administration). 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 11 Jan 2024.