A Mass Balance Study of [14C]HS-10504

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

This study is a single-site, non randomized, open-label study to assess the absorption, metabolism, and excretion profile of \[14C\] HS-10504 in healthy adult male subjects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subjects must be healthy adult males.

Aged 18 years or older.

BMI between 19.0 and 26.0 kg/m² (inclusive) and weight no less than 50 kg (inclusive).

Able and willing to provide written informed consent voluntarily.

Disqualifiers

Clinically significant abnormalities in comprehensive physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, thyroid function, coagulation function, urinalysis, stool routine and occult blood), 12-lead electrocardiogram, ophthalmic examination (slit lamp, intraocular pressure, and fundus photography), chest X-ray (posteroanterior view), digital rectal examination, abdominal ultrasound (liver, gallbladder, pancreas, and spleen), urinary system ultrasound (kidney, ureter, bladder, and prostate), echocardiography, etc.;

Use of any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements (except topical agents with local effects) within 30 days prior to screening, or use of any drug with a washout period of less than 7 half-lives (whichever is longer) before screening;

Participation in other clinical trials and use of other investigational drugs or devices within 3 months prior to screening or during the screening period, or planned participation in another clinical trial during this study;

History of any clinically significant disease or condition that may affect the study results, as judged by the investigator, including but not limited to cardiovascular, respiratory, endocrine, neurological, digestive, urinary, or hematological, immune, psychiatric, or metabolic diseases; or onset of a new illness before study drug administration that is considered by the investigator to make the subject unsuitable for participation;

Trial design

Design model

Single group

Treatments tested in this trial

  • [¹⁴C]HS-10504

    Drug

    \[¹⁴C\]HS-10504: Participants will receive a single oral administration of approximately 400 mg/200 μCi \[¹⁴C\]HS-10504 under fasting conditions on day 1 morning.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total radiorecovery and cumulative radiorecovery in urine and feces per time interval.

To assess the routes and rates of elimination of HS-10504 and its metabolites after single oral administration of \[14C\]HS-10504 in healthy adult male participants.

Time frame
All excreted urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
2

Percentage of major metabolites in human plasma, urine, and feces.

To determine the metabolism and elimination pathways of HS-10504 after single oral administration of \[14C\]HS-10504 in healthy adult male subjects, and identify major metabolites.

Time frame
Plasma, urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
3

The percentage of plasma total radioactivity exposure accounted for by the parent compound and its metabolites (%AUC).

To evaluate the percentage of plasma total radioactivity exposure accounted for by the parent compound and its metabolites.

Time frame
Plasma samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.
4

The percentage of the administered dose recovered as parent drug and metabolites in urine and feces

To evaluate the percentage of the administered dose recovered as parent drug and metabolites in urine and feces.

Time frame
Urine and feces samples from pre-dose to Day 21(504 hours) or meet the protocol-specified criteria for termination of sample collection.

Secondary outcomes

1

total radioactivity in human plasma and whole blood (if applicable)

To evaluate total radioactivity in human plasma and whole blood (if applicable)

Time frame
From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
2

the concentration ratio of total radioactivity in whole blood to that in plasma at different time points.

the concentration ratio of total radioactivity in whole blood to that in plasma at different time points.

Time frame
From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
3

Cmax

To evaluate the Cmax of HS-10504 and its metabolite M6-2 in plasma.

Time frame
From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.
4

Tmax

To evaluate the Tmax of HS-10504 and its metabolite M6-2 in plasma.

Time frame
From pre-dose to Day 21 or meet the protocol-specified criteria for termination of sample collection.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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