Healthy Male SubjectsPhase 1NCT05072028
Mass Balance and Biotransformation Study of [14C]DBPR108 in Human
A Phase 1 study testing [14C]DBPR108 in people with Healthy Male Subjects, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, open-label phase I clinical study to evaluate the mass balance and biotransformation pathways of [14C]DBPR108 in Chinese healthy adult male subjects, to reveal the overall pharmacokinetic characteristics of DBPR108 in human body, and to provide a reference for the rational administration. 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 Male Subjects
- What is being tested?
- [14C]DBPR108
- 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
- 16 Nov 2021to 28 Nov 2021
- 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 adults;
- 18 to 45 years (inclusive);
- Subjects weight ≥50.0 kg and body mass index (BMI) between18-26 kg/m^2 (inclusive) (BMI= weight (kg)/height^2 (m^2);
- Medical history, vital signs examination, physical examination, laboratory tests (blood routine, blood biochemistry, urine routine, thyroid function) and other test results of subjects judged to be normal or abnormal without clinical significance;
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.
Who cannot join
- Clinically significant abnormal results for physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, coagulation routine, urine routine, stool routine + occult blood, thyroid function, glycated hemoglobin), 12-lead electrocardiogram (ECG), chest CT scan, and abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, and kidney);
- Any positive test result of hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;
- Subjects with a history of severe hypoglycemia, such as drowsiness, disturbance of consciousness, or even coma due to hypoglycemia;
- History of acute and chronic pancreatitis, or a history of cholecystitis, gallstones, and pancreatic injury and other high-risk factors that may cause pancreatitis;
- Subjects are hard to swallow, or have diseases affecting drug absorption, distribution, metabolism, excretion;
- History of gastrointestinal ulcer or bleeding;
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- History of any clinically significant diseases, such as circulatory, endocrine, neurological, gastrointestinal, urinary, hematological, immunological, psychiatric and metabolic diseases;
- History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsade de pointes ventricular tachycardia, ventricular tachycardia, prolonged QT syndrome, or symptoms of prolonged QT syndrome and family history;
- Have a major surgery or incomplete incision healing within 6 months prior to screening. Major surgery includes, but is not limited to, any surgery involving a significant risk of bleeding, prolonged general anesthesia, or open biopsy or obvious traumatic injury;
- History of needle sickness or blood sickness, difficulty in blood collection or intolerance to venipuncture blood collection;
- Have hemorrhoids or perianal disease with regular/ongoing bleeding stools;
- Have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease;
- Have a history of allergic conditions, or have a history of allergy to any of DBPR108 or other similarly structured drugs. Those who cannot follow a uniform diet.
- Subjects are lactose intolerant or have rare genetic galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption;
- Use of any metabolizing enzyme inducers or inhibitors within 30 days prior to screening;
- Use of any prescription drug, over-the-counter drug, proprietary Chinese medicine, herbal medicine, vitamins and supplements within 2 weeks prior to screening;
- Have been vaccinated within 4 weeks prior to screening or who have a scheduled vaccinated plan during the study period;
- Participation in another clinical trial within 3 months before screening (whichever is administrated);
- Average weekly intake of alcohol is more than 14 units alcohol (1 units ≈ 360 mL beer, or 45 mL spirits with 40% content, or 150 mL wine) within the 6 months prior to screening, or a positive ethanol breath test at screening;
- Smoking more than 5 cigarettes per day within 3 months prior to screening, or who cannot stop using any tobacco products during the study period;
- History of drug abuse, or positive urine drug screen at screening;
- Subjects who have a habitual consumption of grapefruit juice or excessive amounts of tea, coffee and/or caffeinated beverages (such as coffee, tea, cola, chocolate, energy drinks), and unable to quit during the study period;
- Workers engaged in long-term exposure to radioactive conditions, or have had significant radiation exposure (≥2 chest/abdominal CT scans, or ≥3 other types of X-rays) or participated in the radiopharmaceuticals labeling test within 1 year prior to the study;
- Subjects who have fertility or sperm donation plans, or do not agree to use strict contraceptive methods during the study period and within 1 year after the completion of the study;
- Blood donation (or blood loss) ≥400 mL within 3 months, or receiving whole blood transfusions or erythrocyte suspension transfusions within 1 month prior to the screening;
- Not suitable for this study as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]DBPR108 in Chinese Healthy Adult Male Subjects- Mass Balance and Biotransformation Study of [14C]DBPR108 in Human
This is a single-center, open-label phase I clinical study to evaluate the mass balance and biotransformation pathways of [14C]DBPR108 in Chinese healthy adult male subjects, to reveal the overall pharmacokinetic characteristics of DBPR108 in human body, and to provide a reference for the rational administration.
Read the detailed description
This study will evaluate the mass balance and pharmacokinetics of DBPR108 in approximately 6 healthy male subjects receiving a single oral 100 mg dose of DBPR108 containing approximately 150 µCi of [14C]- DBPR108. This study consists of a screening period (Day -7 to Day -2), a baseline period (Day -1), a treatment period, and a follow-up visit period.
- Conditions
- Healthy Male Subjects
- Being tested
- [14C]DBPR108
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]DBPR108Drug
[14C]DBPR108, single dose of 100 mg (radioactivity of 150 µCi), oral
| Study group | Role | What they receive |
|---|---|---|
| [14C]DBPR108 | Experimental | Subjects will receive a single oral 100 mg (radioactivity of 150 µCi) dose of [14C]DBPR108 on Day 1. Receives: Drug: [14C]DBPR108 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity in urine and feces
Measured: From time zero up to 240 hours post-dose following oral administration of [14] DBPR108
Peak plasma concentration (Cmax)
Measured: From time zero up to 96 hours post-dose following oral administration of [14] DBPR108
Area under the plasma concentration versus time curve from time zero to the last measurable concentration (AUClast)
Measured: From time zero up to 96 hours post-dose following oral administration of [14] DBPR108
Area under the plasma concentration versus time curve from time zero to infinity (AUCinf)
Measured: From time zero up to 96 hours post-dose following oral administration of [14] DBPR108
Time to achieve maximum plasma concentration (Tmax)
Measured: From time zero up to 96 hours post-dose following oral administration of [14] DBPR108
Secondary outcomes (1)
Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0
Measured: From time zero up to 240 hours post-dose following oral administration of [14] DBPR108
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start16 Nov 2021
- Primary completion28 Nov 2021
- Study completion28 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072028
- Sponsor's protocol ID
- HA1118-CSP-011
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 3 Jan 2022
- 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 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]DBPR108 in Chinese Healthy Adult Male Subjects- Mass Balance and Biotransformation Study of [14C]DBPR108 in Human
- ClinicalTrials.gov ID
- NCT05072028
- Acronym / sponsor ID
- HA1118-CSP-011
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 28 Nov 2021 (actual)
- Study completion
- 28 Nov 2021 (actual)
- First posted
- 8 Oct 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 is a single-center, open-label phase I clinical study to evaluate the mass balance and biotransformation pathways of [14C]DBPR108 in Chinese healthy adult male subjects, to reveal the overall pharmacokinetic characteristics of DBPR108 in human body, and to provide a reference for the rational administration.
Detailed description
This study will evaluate the mass balance and pharmacokinetics of DBPR108 in approximately 6 healthy male subjects receiving a single oral 100 mg dose of DBPR108 containing approximately 150 µCi of [14C]- DBPR108. This study consists of a screening period (Day -7 to Day -2), a baseline period (Day -1), a treatment period, and a follow-up visit period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]DBPR108 | Experimental | Drug: [14C]DBPR108Subjects will receive a single oral 100 mg (radioactivity of 150 µCi) dose of [14C]DBPR108 on Day 1. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male adults;
- 18 to 45 years (inclusive);
- Subjects weight ≥50.0 kg and body mass index (BMI) between18-26 kg/m^2 (inclusive) (BMI= weight (kg)/height^2 (m^2);
- Medical history, vital signs examination, physical examination, laboratory tests (blood routine, blood biochemistry, urine routine, thyroid function) and other test results of subjects judged to be normal or abnormal without clinical significance;
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.
Key exclusion criteria (26 listed)
- Clinically significant abnormal results for physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, coagulation routine, urine routine, stool routine + occult blood, thyroid function, glycated hemoglobin), 12-lead electrocardiogram (ECG), chest CT scan, and abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, and kidney);
- Any positive test result of hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;
- Subjects with a history of severe hypoglycemia, such as drowsiness, disturbance of consciousness, or even coma due to hypoglycemia;
- History of acute and chronic pancreatitis, or a history of cholecystitis, gallstones, and pancreatic injury and other high-risk factors that may cause pancreatitis;
- Subjects are hard to swallow, or have diseases affecting drug absorption, distribution, metabolism, excretion;
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]DBPR108[14C]DBPR108, single dose of 100 mg (radioactivity of 150 µCi), oral | Drug | [14C]DBPR108 |
Primary outcome
Total radioactivity in urine and feces
Time frame: From time zero up to 240 hours post-dose following oral administration of [14] DBPR108
Peak plasma concentration (Cmax)
Time frame: From time zero up to 96 hours post-dose following oral administration of [14] DBPR108
Area under the plasma concentration versus time curve from time zero to the last measurable concentration (AUClast)
Time frame: From time zero up to 96 hours post-dose following oral administration of [14] DBPR108
Area under the plasma concentration versus time curve from time zero to infinity (AUCinf)
Time frame: From time zero up to 96 hours post-dose following oral administration of [14] DBPR108
Time to achieve maximum plasma concentration (Tmax)
Time frame: From time zero up to 96 hours post-dose following oral administration of [14] DBPR108
1 secondary outcome
Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From time zero up to 240 hours post-dose following oral administration of [14] DBPR108
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 3 Jan 2022.
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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 [14C]DBPR108 in people with Healthy Male Subjects, run by CSPC ZhongQi Pharmaceutical Technology 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 5 inclusion and 26 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 3 Jan 2022. 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?
Total radioactivity in urine and feces (time frame: From time zero up to 240 hours post-dose following oral administration of [14] DBPR108). The study lists 5 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 3 Jan 2022.