Metabolism of Radioactive SubstancesPhase 1NCT06823232

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

A Phase 1 study testing [14C]XY0206 in people with Metabolism of Radioactive Substances, run by Shijiazhuang Yiling Pharmaceutical Co. Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Metabolism of Radioactive Substances
What is being tested?: [14C]XY0206
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: 6 Nov 2024to 5 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

Healthy adult males;
Age: 18-45 years old (including boundary values);
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);
Voluntary signing of informed consent form; The subjects are able to communicate well with the researchers and complete the experiment according to the protocol.

Who cannot join

Supplementary Examination:
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;
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;
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:
Have used any drugs that inhibit or induce liver drug metabolizing enzymes within 28 days prior to administration (see Appendix 1 for details);

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Any medication that may cause QTc interval prolongation has been used within 28 days prior to administration (see Appendix 2 for details);
Have used any prescription, over-the-counter, herbal or health supplements within 14 days prior to administration;
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;
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:
9) 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

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Gaobo Hospital, Life Science Park Road, Changping District, Beijing
Beijing, Beijing Municipality, 102200

Other trials in China

About this study

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。

Conditions: Metabolism of Radioactive Substances
Being tested: [14C]XY0206

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[14C]XY0206Drug
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).

Study groups in NCT06823232
Study group	Role	What they receive
[14C]XY0206	Experimental	37.5 mg/100 µCi [14C]XY0206 Receives: Drug: [14C]XY0206

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 22 days
Radioactive blood sample
The total radioactive concentration of plasma samples is less than 3 times the background value
Measured: 22 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Nov 20245 Dec 2024

First posted12 Feb 2025
Study start6 Nov 2024
Primary completion5 Dec 2024
Study completion5 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolism of Radioactive SubstancesStudies of the same condition, open and under way.
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
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06823232
Sponsor's protocol ID: XY0206AML1006
Status last verified: Dec 2024
First submitted: 7 Feb 2025
Last updated: 12 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study on the Substance Balance of [14C]XY0206 in Healthy Adult Chinese Men
ClinicalTrials.gov ID: NCT06823232
Acronym / sponsor ID: XY0206AML1006
Conditions: Metabolism of Radioactive Substances
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Shijiazhuang Yiling Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
Study start: 6 Nov 2024 (actual)
Primary completion: 5 Dec 2024 (actual)
Study completion: 5 Dec 2024 (actual)
First posted: 12 Feb 2025 (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.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
[14C]XY0206	Experimental	Drug: [14C]XY020637.5 mg/100 µCi [14C]XY0206

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy adult males;
Age: 18-45 years old (including boundary values);
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);
Voluntary signing of informed consent form; The subjects are able to communicate well with the researchers and complete the experiment according to the protocol.

Key exclusion criteria (12 listed)

Supplementary Examination:
9) 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

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]XY0206On 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).	Drug	[14C]XY0206

Primary outcome

excrement
Time frame: 22 days
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.
Radioactive blood sample
Time frame: 22 days
The total radioactive concentration of plasma samples is less than 3 times the background value

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 12 Feb 2025.
Individual participant dataSharing planned: No

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]XY0206 in people with Metabolism of Radioactive Substances, run by Shijiazhuang Yiling 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 4 inclusion and 12 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 12 Feb 2025. 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?

excrement (time frame: 22 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06823232.

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 12 Feb 2025.