Phase 1 Study, Healthy VolunteersPhase 1NCT05868967
A Clinical Study to Investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects
A Phase 1 study testing [14C]DWP14012 in people with Phase 1 Study, Healthy Volunteers, run by Daewoong Pharmaceutical Co. LTD. at 1 site in China.
Trial summary
The purpose of this study is to investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese 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
- Phase 1 Study, Healthy Volunteers
- What is being tested?
- [14C]DWP14012
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2023to 31 Oct 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 18 to 45 years (including boundary values);
- Body weight ≥ 50.0 kg and body mass index (BMI) between 19.0 and 26.0 kg/m2 (including boundary values);
- Subjects must give informed consent to this study before the study and voluntarily sign a written informed consent form;
- Have no plan for fertility/sperm donation during the study and within 1 year after completion of the study, and take strict contraceptive measures with their spouses (see Appendix 3 for details);
- Have good hygiene habits, and are able to communicate well with the investigator and complete the study in accordance with the study regulations.
Who cannot join
- Subjects with an allergic constitution, including those with a history of drug allergy or allergic reactions and are known to be allergic to this product or other P-CABs, PPIs or other drugs (e.g., aspirin and antibiotics); and those who are allergic to any food ingredients or have special requirements for diet and unable to take the unified diet;
- Subjects with clinically significant abnormalities or medical history of hepatic, renal, gastrointestinal, neurological, respiratory, endocrine, hematological, oncological, cardiovascular, urological, or psychiatric disorders;
- Subjects with abnormal and clinically significant results of vital signs, physical examination, laboratory tests (hematology, blood chemistry, urinalysis, coagulation function, thyroid functions (FT3, FT4, TSH), stool routine + occult blood), 12-lead electrocardiogram, abdominal B-ultrasound (hepatobiliary, pancreas, spleen and kidney) as judged by the investigator;
- Subjects who are positive for any one of the hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, and HIV antigen/antibody combination test (primary screening);
- Subjects with any medical condition that, in the opinion of the investigator, may increase the risk during the subject's participation in this study (especially a history of esophageal or gastrointestinal ulcers), may interfere with drug absorption, distribution, metabolism or excretion, or may impair protocol compliance;
- Subjects with frequent alcohol consumption within 6 months prior to screening, i.e., more than 14 units of alcohol per week (1 unit = 285 mL of beer or 25 mL of spirits containing 40% alcohol or 100 mL of wine); or alcoholics; or those with a positive alcohol breath test at screening and baseline admission;
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- Subjects who have smoked more than 5 cigarettes per day or habitually used nicotine-containing products within 3 months before screening and are unable to withdraw during the study;
- Subjects who have used soft drugs (e.g., cannabis) within 3 months before screening or hard drugs (e.g., cocaine, amphetamines, phencyclidine, etc.) within 1 year before screening; or have a history of drug abuse; or have a positive urine drug test at screening and baseline admission;
- Subjects who have taken any investigational product or participated in any clinical trial of drugs within 3 months prior to screening;
- Subjects who have participated in blood donation within 3 months prior to screening with a total blood donation of ≥ 400 mL or total blood loss of ≥ 400 mL, or who have participated in blood donation within one month prior to screening with a total blood donation of ≥ 200 mL or total blood loss of ≥ 200 mL; or who have received blood transfusion; or who plan to donate blood within 1 month after the end of this study;
- Subjects who have used any medication that alters liver enzyme activity within 4 weeks prior to dosing (see Appendix 1 for details);
- Subjects who have used any prescription or over-the-counter drugs, any vitamin products, health care drugs or Chinese herbal medicines within 14 days prior to dosing;
- Subjects who have habitual consumption of grapefruit juice or excessive amounts of tea, coffee and/or caffeine-containing beverages, and are unable to withdraw during the study;
- Subjects with a history of fear of needles and hemophobia, difficulty in blood collection or intolerance to venipuncture blood collection; radiopharmaceutical labeling studies;
- Subjects whose work requires long-term exposure to radioactive conditions; or who have significant radioactive exposure (≥ 2 chest/ abdominal CTs, or ≥ 3 other types of X-rays) within 1 year prior to screening; or who have participated in radiopharmaceutical labeling studies;
- Subjects with other factors that are not suitable for participation in this study as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects
Read the detailed description
This study is a single-center, single-dose, non-randomized, open-label design with two parts. Each subject will receive a single oral dose of [14C]DWP14012 suspension (containing approximately 40 mg/80 μCi [14C]DWP14012) under the fasting conditions
- Conditions
- Phase 1 Study, Healthy Volunteers
- Being tested
- [14C]DWP14012
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]DWP14012Drug
Each subject will receive a single oral dose of [14C]DWP14012 suspension (containing approximately 40 mg/80 μCi [14C]DWP14012) under fasting conditions.
| Study group | Role | What they receive |
|---|---|---|
| [14C]DWP14012 | Experimental | Type: [14C]DWP14012 suspension containing 40 mg/80 μCi Dosage: orally take the suspension Receives: Drug: [14C]DWP14012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax
Time to peak Concentration
Measured: Up to 168hours(approx) from administration
Cmax
Maximum Concentration
Measured: Up to 168hours(approx) from administration
AUC0-t
Area under the plasma concentraion-time curve
Measured: Up to 168hours(approx) from administration
AUC0-∞
Area under the curve from time 0 extrapolated to infinite time
Measured: Up to 168hours(approx) from administration
t1/2
Elimination Phase Half-life
Measured: Up to 168hours(approx) from administration
MRT
Mean Residence Time
Measured: Up to 168hours(approx) from administration
CL/F
apparent oral clearnace
Measured: Up to 168hours(approx) from administration
Vd/F
apparent oral volume of distribution
Measured: Up to 168hours(approx) from administration
Ratio of total radioactivity in whole blood/plasma
Total measured radioactivity content of urine and fecal samples collected at each sampling interval
Measured: Up to 168hours(approx) from administration
Cumulative recovery of total radioactive substances
Measurement of cumulative recovery ratio in urine or/and feces to meet the criteria for termination
Measured: Up to 168hours(approx) from administration
Secondary outcomes (1)
To observe the safety of [14C]DWP14012
Adverse events, serious adverse events etc.
Measured: Up to study completion, approximately up to 2000 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start27 Feb 2023
- Primary completion31 May 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase 1 Study, Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical 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
- Model description
- A single-center, single-dose, open-label design
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Haini Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Fang Hou, Principal investigator, Beijing GoBroad Boren HospitalWel Tan, Principal investigator, Beijing GoBroad Boren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868967
- Sponsor's protocol ID
- DW_DWP14012112
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 22 May 2023
- 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 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT05868967
- Acronym / sponsor ID
- DW_DWP14012112
- Conditions
- Phase 1 Study, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Haini Pharmaceutical Co., Ltd.
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 22 May 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.
The purpose of this study is to investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects
Detailed description
This study is a single-center, single-dose, non-randomized, open-label design with two parts. Each subject will receive a single oral dose of [14C]DWP14012 suspension (containing approximately 40 mg/80 μCi [14C]DWP14012) under the fasting conditions
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-center, single-dose, open-label design
| Arm | Type | Receives |
|---|---|---|
| [14C]DWP14012 | Experimental | Drug: [14C]DWP14012Type: [14C]DWP14012 suspension containing 40 mg/80 μCi Dosage: orally take the suspension |
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 to 45 years (including boundary values);
- Body weight ≥ 50.0 kg and body mass index (BMI) between 19.0 and 26.0 kg/m2 (including boundary values);
- Subjects must give informed consent to this study before the study and voluntarily sign a written informed consent form;
- Have no plan for fertility/sperm donation during the study and within 1 year after completion of the study, and take strict contraceptive measures with their spouses (see Appendix 3 for details);
- Have good hygiene habits, and are able to communicate well with the investigator and complete the study in accordance with the study regulations.
Key exclusion criteria (16 listed)
- Subjects with an allergic constitution, including those with a history of drug allergy or allergic reactions and are known to be allergic to this product or other P-CABs, PPIs or other drugs (e.g., aspirin and antibiotics); and those who are allergic to any food ingredients or have special requirements for diet and unable to take the unified diet;
- Subjects with clinically significant abnormalities or medical history of hepatic, renal, gastrointestinal, neurological, respiratory, endocrine, hematological, oncological, cardiovascular, urological, or psychiatric disorders;
- Subjects with abnormal and clinically significant results of vital signs, physical examination, laboratory tests (hematology, blood chemistry, urinalysis, coagulation function, thyroid functions (FT3, FT4, TSH), stool routine + occult blood), 12-lead electrocardiogram, abdominal B-ultrasound (hepatobiliary, pancreas, spleen and kidney) as judged by the investigator;
- Subjects who are positive for any one of the hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, and HIV antigen/antibody combination test (primary screening);
- Subjects with any medical condition that, in the opinion of the investigator, may increase the risk during the subject's participation in this study (especially a history of esophageal or gastrointestinal ulcers), may interfere with drug absorption, distribution, metabolism or excretion, or may impair protocol compliance;
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]DWP14012Each subject will receive a single oral dose of [14C]DWP14012 suspension (containing approximately 40 mg/80 μCi [14C]DWP14012) under fasting conditions. | Drug | [14C]DWP14012 |
Primary outcome
Tmax
Time frame: Up to 168hours(approx) from administration
Time to peak Concentration
Cmax
Time frame: Up to 168hours(approx) from administration
Maximum Concentration
AUC0-t
Time frame: Up to 168hours(approx) from administration
Area under the plasma concentraion-time curve
AUC0-∞
Time frame: Up to 168hours(approx) from administration
Area under the curve from time 0 extrapolated to infinite time
t1/2
Time frame: Up to 168hours(approx) from administration
Elimination Phase Half-life
MRT
Time frame: Up to 168hours(approx) from administration
Mean Residence Time
CL/F
Time frame: Up to 168hours(approx) from administration
apparent oral clearnace
Vd/F
Time frame: Up to 168hours(approx) from administration
apparent oral volume of distribution
Ratio of total radioactivity in whole blood/plasma
Time frame: Up to 168hours(approx) from administration
Total measured radioactivity content of urine and fecal samples collected at each sampling interval
Cumulative recovery of total radioactive substances
Time frame: Up to 168hours(approx) from administration
Measurement of cumulative recovery ratio in urine or/and feces to meet the criteria for termination
1 secondary outcome
To observe the safety of [14C]DWP14012
Time frame: Up to study completion, approximately up to 2000 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 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.
Fang Hou principal investigator
Beijing GoBroad Boren Hospital
Wel Tan principal investigator
Beijing GoBroad Boren Hospital
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]DWP14012 in people with Phase 1 Study, Healthy Volunteers, run by Daewoong Pharmaceutical 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 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: status not confirmed, as of the sponsor's last update on 22 May 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?
Results are not available in the source record.
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?
Tmax (time frame: Up to 168hours(approx) from administration). 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 22 May 2023.