Mass Balance Study of [14C]RAY1216 in Healthy Adult Male Subjects in China

NCT06362460 | Completed Phase 1

• 1 other identifier: RAY1216-23-03
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of \[14C\]RAY1216 in healthy Chinese male participants, revealing the overall pharmacokinetic characteristics of RAY1216.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (5)

• Total radioactivity in plasma PK

  Cmax

  Up to 7 days from the start of administration.

• Total radioactivity in plasma PK

  AUC0-t

  Up to 7 days from the start of administration.

• Total radioactivity in plasma PK

  CL/F

  Up to 7 days from the start of administration.

• Total radioactivity in plasma PK

  Vz/F

  Up to 7 days from the start of administration.

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

  Up to 14 days from the start of administration.

Secondary Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

  Up to 14 days (approx) from the start of administration.

Study Arms (1)

[14C]RAY1216

EXPERIMENTAL

Drug: [14C] RAY1216

Interventions

[14C] RAY1216 DRUG

400 mg suspension containing 100μCi of \[14C\]RAY1216

[14C]RAY1216

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and female participants between 18-45 years (Both inclusive);
• Body weight≥50kg.Body mass index (BMI) 18\~28 kg/m2 (Both inclusive); BMI is determined by the following equation: BMI = weight/height2 (kg/m2);
• Participants who voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.

You may not qualify if:

• Any clinically significant abnormality upon physical examination or in the clinical laboratory tests. History or presence of a clinically significant gastrointestinal, renal, hepatic, neurologic, hematic, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular disorder(s) (but not limited to above disorders).
• Presence of human immunodeficiency virus (HIV), viral hepatitis(including hepatitis C virus (HCV) or hepatitis B virus (HBV) ,treponema pallidum antibodies at screening.
• Participants who donated blood or bleeding profusely(\> 400 mL)in the 3 months preceding study screening.
• Participants who have undergone surgery within 6 months before the screening period or whose surgical incision is not completely healed; Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, or an open biopsy or significant traumatic injury;
• Workers engaged in conditions requiring long-term exposure to radioactivity; Or have significant radiation exposure (≥2 chest/abdomen CT, or ≥3 other types of X-ray examinations) within 1 year before this study or have participated in the radiopharmaceutical labeling test;
• Participants who smoked an average of \>5 cigarettes per day in the previous 3 months or habitually used nicotine-containing products and were unable to quit during the trial period;
• Substance abuse or use of soft drugs (e.g., marijuana) in the 3 months prior to the screening period or use of hard drugs (e.g., cocaine, amphetamines, etc.) in the 1 year prior to the screening period; Or screening for positive urine drug abuse (drug) tests;
• Participants who have special dietary requirements and cannot comply with a uniform diet;
• History of allergic conditions or allergic diseases, or a history of allergic reactions attributed to RAY1216 or any of the ingredients of its formulation or similar drugs.

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Location

Study Design

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

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: September 18, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 15, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

CN (1)