A Study to Evaluate the Mass Balance of [14C] SY-5007 in Healthy Adult Male Subjects in China

NCT06352190 | Unknown Phase 1

• 1 other identifier: SY-5007-I-04
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled SY-5007 administered orally.

Conditions

Healthy Subjects

Keywords

[14C] SY-5007; Mass Balance

Outcome Measures

Primary Outcomes (8)

• Total radioactivity in plasma PK: Cmax

  Highest radioactivity observed plasma concentration

  At pre-dose and up to 2 weeks post-dose

• Total radioactivity in plasma PK: Tmax

  Time to reach the Cmax

  At pre-dose and up to 2 weeks post-dose

• Total radioactivity in plasma PK: AUC0-t

  Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration

  At pre-dose and up to 2 weeks post-dose

• Total radioactivity in plasma PK: t½

  Defined as apparent plasma terminal phase disposition half-life

  At pre-dose and up to 2 weeks post-dose

• Total radioactivity in plasma PK: CL/F

  Defined as apparent total body clearance

  At pre-dose and up to 2 weeks post-dose

• Whole blood to plasma total radioactivity ratio

  To evaluate the extent of distribution of total radioactivity into blood cells

  At pre-dose and up to 2 weeks post-dose

• Cumulative total radioactivity in urine and faeces

  Mass balance recovery of total radioactivity in all (urine, faeces) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae)

  At pre-dose and up to 2 weeks post-dose

• Metabolic profiling in plasma, urinary and fecal excretion

  To characterize the metabolic profile and identify circulating and excreted metabolites of SY-5007 using liquid chromatography with mass spectral detection.

  At pre-dose and up to 2 weeks post-dose

Secondary Outcomes (6)

• Cmax of SY-5007 and its metabolites

  At pre-dose and up to 2 weeks post-dose

• Tmax of SY-5007 and its metabolites

  At pre-dose and up to 2 weeks post-dose

• AUC0-t of SY-5007 and its metabolites

  At pre-dose and up to 2 weeks post-dose

• t½ of SY-5007 and its metabolites

  At pre-dose and up to 2 weeks post-dose

• CL/F of SY-5007 and its metabolites

  At pre-dose and up to 2 weeks post-dose

Study Arms (1)

SY-5007

EXPERIMENTAL

Single oral dose of 160 mg SY-5007 suspension (containing approximately 120 μCi \[14C\] SY-5007)

Drug: [14C] SY-5007

Interventions

[14C] SY-5007 DRUG

Carbon-14 labeled SY-5007

SY-5007

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must meet all of the following criteria to be enrolled in this study:
• Fully informed, able to communicate effectively with researchers, agree to abide by the protocol and trial management regulations, and voluntarily sign the written Informed Consent Form (ICF);
• Healthy adult males aged 18 to 50 years at the time of signing the ICF, with no plans for reproduction or sperm donation within the past 2 years;
• Weight ≥ 50 kg and body mass index (BMI) between 18 and 26 kg/m2;
• Subjects of reproductive capability agree to employ effective contraceptive measures with their sexual partners during the study period and for 2 years following the end of the study.

You may not qualify if:

• Subjects meeting any of the following criteria are ineligible for participation in this study:
• History of allergies (such as allergies to two or more drugs, foods, or pollen, or individuals prone to skin hives or allergic reactions).
• Positive for hepatitis B surface antigen, hepatitis C virus antibodies, human immunodeficiency virus antibodies, or positive for syphilis treponemal and non-treponemal antibodies during screening.
• Abnormal clinically significant vital signs, physical examinations, laboratory tests, or electrocardiograms at screening.
• Gastrointestinal, hepatic, or renal diseases that may affect drug pharmacokinetics as assessed by the investigator at screening.
• History of drug abuse or illicit drug use within 12 months prior to the first dose administration, or positive urine drug screening test during screening.
• Underwent major surgery within 6 months prior to the first dose administration, or planned to undergo surgery during the trial period.
• History of any clinically significant illness within 3 months prior to the first dose administration or conditions deemed by the investigator to potentially affect trial outcomes, including but not limited to cardiovascular, endocrine, nervous, respiratory, digestive, urinary, hematologic, immune, or psychiatric disorders.
• Average daily smoking of more than 5 cigarettes within 3 months prior to the first dose administration, or unwillingness to discontinue use of any tobacco products during the trial.
• Regular alcohol consumption within 3 months prior to the first dose administration \[defined as consuming more than 14 units of alcohol per week (1 unit = 360mL of 5% alcohol beer or 45mL of 40% alcohol liquor or 150mL of 12% alcohol wine)\], or inability to abstain from alcohol during the trial, or positive alcohol breath test during screening.
• History of blood donation or significant blood loss (≥ 300mL) within 3 months prior to the first dose administration, or use of blood products or blood transfusion within 1 month prior to the first dose administration.
• Participation in other drug or medical device clinical trials within 3 months prior to the first dose administration (excluding screen failures), or prior use of the investigational drug.
• Vaccination within 1 month prior to the first dose administration.
• Use of any prescription drugs, over-the-counter drugs, supplements, or herbal remedies within 2 weeks prior to the first dose administration (if the half-life \[t1/2\] of the drug can be confirmed, a washout period of 5 times of t1/2 is required).
• Habitual consumption of more than 8 cups (1 cup = 250mL) of tea, coffee, or caffeinated beverages and unable to abstain from consumption within 48 hours prior to the first dose administration and during the trial.

Sponsors & Collaborators

• Shouyao Holdings (Beijing) Co. LTD: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, 100050, China

Location

Study Officials

• Yinghui Sun, PhD

  Shouyao Holdings (Beijing) Co. LTD

  STUDY DIRECTOR

Central Study Contacts

Yinghui Sun, PhD

CONTACT

86-10-88858616; yhsun@centaurusbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: May 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 8, 2024

Record last verified: 2023-12

Locations

CN (1)