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CompletedNCT06823232Updated Feb 12, 2025

A Study on the Substance Balance of [14C]XY0206 in Healthy Adult Chinese Men

A Phase 1 interventional study of [14C]XY0206 in Metabolism of Radioactive Substances, sponsored by Shijiazhuang Yiling Pharmaceutical Co. Ltd. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Shijiazhuang Yiling Pharmaceutical Co. Ltd · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2024, registered Feb 2025).
Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

The main purpose of this clinical trial is to quantitatively analyse the total radioactivity in the excreta of subjects after oral administration of [14C]XY0206, and to obtain data on human radioactive excretion rate and main excretion routes and the radioactivity of human plasma, urine, and faeces after oral administration of [14C]XY0206 by subjects Metabolite profiling, identification of major metabolites, determination of metabolic pathways and elimination pathways; Subjects who met the criteria fasted for at least 10h before administration and took [14C]XY0206 suspension (containing about 37.5mg/100µCi[14C]XY0206) orally on an empty stomach in the morning of the first day of administration (DI).Subjects will also complete urine, stool and blood collection within a specified period of time。

02

Conditions studied

  • Metabolism of Radioactive Substances
03

In context

Lead sponsor

Shijiazhuang Yiling Pharmaceutical Co. Ltd is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy adult males;
  2. Age: 18-45 years old (including boundary values);
  3. Weight: The subject's weight is not less than 50 kg, and their body mass index (BMI) is between 19-26 kg/m2 (including boundary values);
  4. Voluntary signing of informed consent form; The subjects are able to communicate well with the researchers and complete the experiment according to the protocol.

Exclusion criteria

Exclusion Criteria:

  • Supplementary Examination:

    1. Individuals who have undergone comprehensive physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine+occult blood), thyroid function, chest X-ray, abdominal ultrasound (liver, gallbladder, pancreas, spleen and kidney), and other examinations that are abnormal and clinically significant;
    2. Patients with clinically significant abnormal 12 lead electrocardiogram during the screening/baseline period, or those with QTc interval (QTcF) ≥ 450 ms corrected according to Fridericia's criteria;
    3. Individuals who are positive for any one of hepatitis B virus surface antigen, hepatitis B virus e antigen, hepatitis B virus core antibody, hepatitis C virus antibody, HIV antibody, and Treponema pallidum antibody.

      Medication history:

    4. Have used any drugs that inhibit or induce liver drug metabolizing enzymes within 28 days prior to administration (see Appendix 1 for details);
    5. Any medication that may cause QTc interval prolongation has been used within 28 days prior to administration (see Appendix 2 for details);
    6. Have used any prescription, over-the-counter, herbal or health supplements within 14 days prior to administration;
    7. Individuals who have participated in any clinical trials and received intervention with investigational drugs or medical devices within the last 3 months prior to the screening period;
    8. Screening individuals who have received the vaccine within the previous month or have a vaccination plan during the trial period;

History of illness and surgery:

  1. Any clinical history of serious diseases or conditions that researchers believe may affect the test results, including but not limited to a history of motor system, nervous system, endocrine system, circulatory system, respiratory system, digestive system, urinary system, reproductive system diseases; 10) History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, twisted ventricular tachycardia, ventricular tachycardia, atrioventricular block, and any type of cardiovascular disease/disease/surgery that may increase QT interval prolongation, or a history of other risk factors leading to TdP (such as hypokalemia, hypomagnesemia, congenital long QT syndrome or family history of long QT syndrome or Brugada syndrome); 11) Having undergone major surgery or incomplete healing of surgical incision within the 6 months prior to the screening period; Major surgeries include but are not limited to any surgery involving significant bleeding risks, prolonged general anesthesia, or open biopsy or significant traumatic injuries; 12) Allergic constitution, such as those with a known history of allergies to two or more substances; Or those who may be allergic to the investigational drug or its excipients, as determined by researchers; 13) Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (such as inability to swallow, intestinal obstruction, digestive ulcers, etc.); Hemorrhoids or perianal diseases with regular/ongoing rectal bleeding, irritable bowel syndrome, inflammatory bowel disease; habits and customs: 15) Habitual constipation or diarrhea; 16) Excessive drinking or frequent alcohol consumption within the first 6 months of the screening period, i.e. drinking more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); 17) Individuals who smoke more than 5 cigarettes per day or habitually use nicotine containing products during the first 3 months of the screening period and are unable to quit during the trial period; 18) Individuals with a history of drug abuse or addiction in the past 5 years; 19) Habitual consumption of grapefruit juice or excessive amounts of tea, coffee, and/or caffeinated beverages, and inability to quit during the trial period; other: 20) Individuals with positive results in urine drug abuse screening and alcohol breath test during the baseline period; 21) Engage in work that requires long-term exposure to radioactive conditions; Or those who have had significant radiation exposure (≥ 2 chest/abdominal CT scans, or ≥ 3 other types of X-ray examinations) or have participated in radiopharmaceutical labeling trials within 1 year prior to the experiment; 22) Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection; 23) Those who have planned to give birth or donate sperm during the trial period and within 6 months after completion of the trial, or those who do not agree that the subjects and their spouses should take strict contraceptive measures during the trial period and within 6 months after completion of the trial; 24)Individuals who have experienced blood loss or donated up to 400 mL of blood within the past 3 months prior to the screening period, or who have received blood transfusions within the past 1 month; 25)Researchers believe that subjects with any factors that are not suitable for participation in this experiment
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    [14C]XY0206

    37.5 mg/100 µCi \[14C\]XY0206

    Drug: [14C]XY0206

Interventions

  • Drug[14C]XY0206

    On the morning of the day of medication (D1), the subject took \[14C\] XY0206 suspension orally on an empty stomach (containing approximately 37.5 mg/100 µ Ci \[14C\] XY0206).

06

What researchers measure

Primary outcomes

  1. excrement

    The total radioactivity of the collected biological samples (urine+feces) from each subject exceeds 90% of the administered dose, and the radioactivity collected for two consecutive days is less than 1% of the administered dose.

    Time frame: 22 days

  2. Radioactive blood sample

    The total radioactive concentration of plasma samples is less than 3 times the background value

    Time frame: 22 days

07

Study locations

1 site
  • Beijing Gaobo Hospital, Life Science Park Road, Changping District, Beijing
    Beijing, Beijing 102200, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06823232
Lead sponsor
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Responsible party
Sponsor
First posted
Feb 12, 2025
Start date
Nov 6, 2024
Primary completion
Dec 5, 2024
Completion
Dec 5, 2024
Last update
Feb 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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