A Study To Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects
A Phase1 Study to Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Liyan Miao
- Phone Number: 0512-67972858
- Email: miaolysuzhou@163.com
Study Locations
-
-
Jiangsu
-
Suzhou, Jiangsu, China
- Recruiting
- The First Affiliated Hospital of Soochow University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: [14C] HDM1002
A single dose of HDM1002 and [14C] HDM1002 administered orally.
|
Administered orally
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Predose up to Day 11 after administration of [14C] HDM1002
|
|
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.
|
Predose up to Day 11 after administration of [14C] HDM1002
|
|
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
|
Predose up to Day 11 after administration of [14C] HDM1002
|
|
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 ∞
|
Predose up to Day 11 after administration of [14C] HDM1002
|
|
Plasma and whole blood Cmax of radioactivity
Time Frame: Predose up to Day 11 after administration of [14C] HDM1002
|
PK parameter : Maximum observed concentration
|
Predose up to Day 11 after administration of [14C] HDM1002
|
|
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
|
Predose up to Day 11 after administration of [14C] HDM1002
|
|
Plasma and whole blood t1/2 of radioactivity
Time Frame: Predose up to Day 11 after administration of [14C] HDM1002
|
PK parameter: Half life
|
Predose up to Day 11 after administration of [14C] HDM1002
|
|
Plasma and whole blood CL/F of radioactivity
Time Frame: Predose up to Day 11 after administration of [14C] HDM1002
|
PK parameter : Apparent Clearance
|
Predose up to Day 11 after administration of [14C] HDM1002
|
|
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
|
Predose up to Day 11 after administration of [14C] HDM1002
|
|
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
|
Predose up to Day 11 after administration of [14C] HDM1002
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma AUC[0-t] of HDM1002 and metabolites
Time Frame: Predose up to Day 11 after administration of [14C] HDM1002
|
PK parameter : Area under the curve from time 0 to t hour
|
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
|
PK parameter : Area under the curve from time 0 hour to ∞
|
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
|
PK parameter : Maximum observed concentration
|
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
|
PK parameter : Time to maximum plasma concentration
|
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
|
PK parameter: Half life
|
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
|
PK parameter : Apparent Clearance
|
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
|
PK parameter : Apparent volume of distribution
|
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
|
Number of subjects reporting AEs
|
Predose up to Day 11 after administration of [14C] HDM1002
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- HDM1002-104
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Adult Subject
-
NCT07594847RecruitingHealthy Adult Subject
-
NCT06562088Not yet recruiting
-
NCT07341672Not yet recruiting
-
NCT06608329Not yet recruitingHealthy Adult Subject
-
NCT06601517Not yet recruitingHealthy Adult Subject | Overweight Subject
-
NCT05921890Completed
-
NCT06037395Completed
Clinical Trials on [14C] HDM1002
-
NCT06481085Completed
-
NCT07193459Recruiting
-
NCT06500299Not yet recruitingOverweight and Obesity
-
NCT06885021Not yet recruitingOverweight and Obesity
-
NCT06520540Not yet recruitingGlucagon-Like Peptide-1 Receptor Agonists
-
NCT07082114Recruiting
-
NCT06985615RecruitingHealthy Volunteers | Hepatic Impairment
-
NCT07594847RecruitingHealthy Adult Subject
-
NCT06608329Not yet recruitingHealthy Adult Subject
-
NCT07334886Completed