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

Pharmacokinetics Clinical Trial

Official title:

Single-center, Open-label, Non-randomized and Single-dose Clinical Trial to Explore the Mass Balance of Oral Suspension of 400mg [14C]RAY1216

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06362460
• Other study ID #: RAY1216-23-03
• Status: Completed
• Phase: Phase 1
• Start date: September 18, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: April 2024
• Source: Guangdong Raynovent Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 15, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Males and female participants between 18-45 years (Both inclusive);

2. 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);

3. Participants who voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.

Exclusion Criteria:

1. 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).

2. Presence of human immunodeficiency virus (HIV), viral hepatitis(including hepatitis C virus (HCV) or hepatitis B virus (HBV) ,treponema pallidum antibodies at screening.

3. Participants who donated blood or bleeding profusely(> 400 mL)in the 3 months preceding study screening.

4. 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;

5. 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;

6. 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;

7. 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;

8. Participants who have special dietary requirements and cannot comply with a uniform diet;

9. 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.

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• [14C] RAY1216
400 mg suspension containing 100µCi of [14C]RAY1216

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Raynovent Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total radioactivity in plasma PK	Cmax	Up to 7 days from the start of administration.
Primary	Total radioactivity in plasma PK	AUC0-t	Up to 7 days from the start of administration.
Primary	Total radioactivity in plasma PK	CL/F	Up to 7 days from the start of administration.
Primary	Total radioactivity in plasma PK	Vz/F	Up to 7 days from the start of administration.
Primary	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	Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0		Up to 14 days (approx) from the start of administration.