Healthy Adult SubjectPhase 1NCT06576401
A Study To Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects
A Phase 1 study testing [14C] HDM1002 in people with Healthy Adult Subject, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
In this study, a single dose of [14C] radiolabelled HDM1002 will be administered orally. The main purpose of this study is to find out how much of HDM1002 and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral [14C] HDM002. 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 Subject
- What is being tested?
- [14C] HDM1002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2024to Dec 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
- Male, healthy adult;
- Age of 18 to 45 years old (both inclusive);
- Body mass index (BMI) between 19.0- 32.0 kg/m2 (both inclusive) and body weight no less than 50.0 kg.
Who cannot join
- Clinically significant diseases at the time of screening;
- History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin ≥ 35 ng/L during the screening period;
- History of chronic pancreatitis or acute pancreatitis within 3 months prior to screening;
- History of acute cholecystitis attack within 3 months prior to screening;
- Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying or affect the absorption of nutrients in the gastrointestinal tract, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.;
- Any of the following: habitual constipation or diarrhea, hemorrhoids or accompanied by perianal disease, irritable bowel syndrome, inflammatory bowel disease, etc;
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- Use of any prescription medication, over-the-counter medication, Chinese herbal medicine or food supplement within 14 days or 5 half-lives (whichever is longer) prior to the screening period;
- Patients with any abnormal and clinically significant examinations in given comprehensive physical examination;
- History of drug abuse (e.g., morphine, ketamine, tetrahydrocannabinolic acid, metham phetamine, methylenedioxyamphetamine, cocaine) or positive urine drug test during the screening period;
- Positive for hepatitis B surface antigen or E antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), human immunodeficiency virus antigen/antibody combination test (HIV-Ag/Ab) and Treponema pallidum antibody during the screening period.
- Engaged in working conditions requiring long-term exposure to radioactivity; or significant radioactive exposure ( ≥ 2 CT chest/abdomen tests, or ≥ 3 all other types of X-rays test) within 1 year prior to the trail, or participated in radio-label trails;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
About this study
Official title: A Phase1 Study to Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects
In this study, a single dose of [14C] radiolabelled HDM1002 will be administered orally. The main purpose of this study is to find out how much of HDM1002 and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral [14C] HDM002.
- Conditions
- Healthy Adult Subject
- Being tested
- [14C] HDM1002
- Keywords
- HDM1002, Glucagon-Like Peptide-1 Receptor Agonists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] HDM1002Drug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| [14C] HDM1002 | Experimental | A single dose of HDM1002 and [14C] HDM1002 administered orally. Receives: Drug: [14C] HDM1002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total recovery of HDM1002 radioactivity in urine and feces, following oral administration of [14C] HDM1002
Total recovery of radioactivity in urine and feces, and both routes combined expressed as a percentage of the total radioactive dose administered
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Metabolite profiling/identification in plasma, urine, and feces
Metabolic profiling/identification and determination of relative abundance of [14C]PF-06882961 and the metabolites of [14C] HDM1002 in plasma, urine, and feces.
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood AUC[0-t] of radioactivity
PK parameter : Area under the curve from time 0 to t hour
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood AUC[0-∞] of radioactivity
PK parameter : Area under the curve from time 0 hour to ∞
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood Cmax of radioactivity
PK parameter : Maximum observed concentration
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood Tmax of radioactivity
PK parameter : Time to maximum plasma concentration
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood t1/2 of radioactivity
PK parameter: Half life
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood CL/F of radioactivity
PK parameter : Apparent Clearance
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Plasma and whole blood Vz/F of radioactivity
PK parameter : Apparent volume of distribution
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Percentage of plasma HDM1002 and metabolites in total plasma radioactivity
Percentage of plasma HDM1002 AUC in total plasma radioactivity AUC
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Secondary outcomes (8)
Plasma AUC[0-t] of HDM1002 and metabolites
PK parameter : Area under the curve from time 0 to t hour
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Plasma AUC[0-∞] of HDM1002 and metabolites
PK parameter : Area under the curve from time 0 hour to ∞
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Plasma Cmax of HDM1002 and metabolites
PK parameter : Maximum observed concentration
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Plasma Tmax of HDM1002 and metabolites
PK parameter : Time to maximum plasma concentration
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Plasma t1/2 of HDM1002 and metabolites
PK parameter: Half life
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Plasma CL/F of HDM1002 and metabolites
PK parameter : Apparent Clearance
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Plasma Vz/F of HDM1002 and metabolites
PK parameter : Apparent volume of distribution
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Adverse events (AEs)
Number of subjects reporting AEs
Measured: Predose up to Day 11 after administration of [14C] HDM1002
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start27 Aug 2024
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectStudies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576401
- Sponsor's protocol ID
- HDM1002-104
- Status last verified
- Sep 2024
- First submitted
- 20 Aug 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase1 Study to Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT06576401
- Acronym / sponsor ID
- HDM1002-104
- Conditions
- Healthy Adult Subject
- Keywords
- HDM1002, Glucagon-Like Peptide-1 Receptor Agonists
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Aug 2024 (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.
In this study, a single dose of [14C] radiolabelled HDM1002 will be administered orally. The main purpose of this study is to find out how much of HDM1002 and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral [14C] HDM002.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C] HDM1002 | Experimental | Drug: [14C] HDM1002A single dose of HDM1002 and [14C] HDM1002 administered orally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male, healthy adult;
- Age of 18 to 45 years old (both inclusive);
- Body mass index (BMI) between 19.0- 32.0 kg/m2 (both inclusive) and body weight no less than 50.0 kg.
Key exclusion criteria (11 listed)
- Clinically significant diseases at the time of screening;
- History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin ≥ 35 ng/L during the screening period;
- History of chronic pancreatitis or acute pancreatitis within 3 months prior to screening;
- History of acute cholecystitis attack within 3 months prior to screening;
- Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying or affect the absorption of nutrients in the gastrointestinal tract, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.;
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] HDM1002Administered orally | Drug | [14C] HDM1002 |
Primary outcome
Total recovery of HDM1002 radioactivity in urine and feces, following oral administration of [14C] HDM1002
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Total recovery of radioactivity in urine and feces, and both routes combined expressed as a percentage of the total radioactive dose administered
Metabolite profiling/identification in plasma, urine, and feces
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Metabolic profiling/identification and determination of relative abundance of [14C]PF-06882961 and the metabolites of [14C] HDM1002 in plasma, urine, and feces.
Plasma and whole blood AUC[0-t] of radioactivity
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Area under the curve from time 0 to t hour
Plasma and whole blood AUC[0-∞] of radioactivity
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Area under the curve from time 0 hour to ∞
Plasma and whole blood Cmax of radioactivity
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Maximum observed concentration
Plasma and whole blood Tmax of radioactivity
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Time to maximum plasma concentration
Plasma and whole blood t1/2 of radioactivity
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter: Half life
Plasma and whole blood CL/F of radioactivity
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Apparent Clearance
Plasma and whole blood Vz/F of radioactivity
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
PK parameter : Apparent volume of distribution
Percentage of plasma HDM1002 and metabolites in total plasma radioactivity
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Percentage of plasma HDM1002 AUC in total plasma radioactivity AUC
8 secondary outcomes
Plasma AUC[0-t] of HDM1002 and metabolites
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma AUC[0-∞] of HDM1002 and metabolites
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma Cmax of HDM1002 and metabolites
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma Tmax of HDM1002 and metabolites
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma t1/2 of HDM1002 and metabolites
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma CL/F of HDM1002 and metabolites
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Plasma Vz/F of HDM1002 and metabolites
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Adverse events (AEs)
Time frame: Predose up to Day 11 after administration of [14C] HDM1002
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
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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.
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] HDM1002 in people with Healthy Adult Subject, run by Hangzhou Zhongmei Huadong 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 3 inclusion and 11 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 4 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liyan Miao (0512-67972858, miaolysuzhou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total recovery of HDM1002 radioactivity in urine and feces, following oral administration of [14C] HDM1002 (time frame: Predose up to Day 11 after administration of [14C] HDM1002). 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 4 Sep 2024.