Health TrialsbyHealthPanel

[¹⁴C] Hydronidone Mass Balance Study

ConditionChronic Hepatitis B-related Liver Fibrosis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-50
SponsorBeijing Continent Pharmaceutical Co, Ltd.

About this trial

According to the "Technical Guidelines for Radioactive Labeled Human Mass Balance Studies" issued by the NMPA, human mass balance studies are an important component of clinical pharmacology research for innovative drugs, and it is recommended that mass balance studies be conducted for all new molecular entities. Therefore, to further clarify the absorption, metabolism, and excretion characteristics of Hydronidone in the human body, a \[¹⁴C\] Hydronidone mass balance study is planned in Chinese healthy adult male participants. This study aims to reveal the pharmacokinetic characteristics of Hydronidone and provide a reference for the rational use of the drug.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants must be fully informed about the study, understand the study content, procedures, and potential adverse events related to the investigational drug, and voluntarily sign a written informed consent form;

Chinese adult male participants aged 18 to 50 years (inclusive);

Participants weighing at least 50 kg at screening, with a body mass index [BMI = weight (kg) / height² (m²)] within the range of 19.0 to 26.0 kg/m² (inclusive);

Participants have no plan to donate sperm within 6 months after dosing; participants and their partners have no pregnancy plan during the study and within 6 months after dosing, and voluntarily agree to use effective contraceptive measures (see Appendix 1 for details; contraceptive pills are prohibited for participants during the study) to avoid pregnancy of the participant's partner.

Disqualifiers

The researcher determines that there are other diseases or medical histories that are clinically significant or may interfere with the participant's ability to comply with the study protocol and complete the study, including but not limited to abnormalities in the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, mental system, and endocrine metabolic system;

Abnormalities in vital signs, physical examination, routine laboratory tests (blood routine, urine routine, stool routine + occult blood, blood biochemistry, coagulation function), 12-lead electrocardiogram, chest X-ray (anterior view), abdominal ultrasound, etc., at screening or baseline, which are determined by the researcher to be clinically significant;

Results from the 12-lead electrocardiogram at screening or baseline showing QTcF ≥ 450ms, or other abnormal electrocardiogram indicators that are clinically significant;

Positive results for any of the following: quantitative determination of hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or human immunodeficiency virus antigen/antibody;

Trial design

Design model

Single group

Treatments tested in this trial

  • [¹⁴C]Hydronidone

    Drug

    Enrolled participants fasted for at least 10 hours prior to dosing. On the morning of Day 1 (D1), a single oral dose of \[¹⁴C\]Hydronidone suspension (containing approximately 90 mg/100 μCi of \[¹⁴C\]Hydronidone) was administered under fasting conditions, with approximately 240 mL of water used for preparation and administration. Except for the water used for dosing, no water was permitted within 1 hour before and after administration. Participants remained in the isotope ward of the study center from dosing until Day 9 (D9), which could be shortened or extended depending on whether the sample collection termination criteria were met."

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: [¹⁴C] Hydronidone suspension (containing approximately 90 mg/100 μCi of [¹⁴C] Hydronidone)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative radioactive recovery in excreta (urine and feces) per collection period

Time frame
within 9 days after dosing
2

Cumulative total radioactive recovery in excreta (urine and feces)

Time frame
within 9 days after dosing
3

Pharmacokinetic parameters of total radioactivity in plasma : Cmax

Time frame
within 9 days after dosing
4

Pharmacokinetic parameters of total radioactivity in plasma : Tmax

Time frame
within 9 days after dosing

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Continent Pharmaceutical Co, Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: