Study of Pharmacokinetics and Metabolism on [(14)C]ADC189

Pharmacokinetics Clinical Trial

Official title:

A Phase I Study to Investigate the Absorption, Metabolism, Excretion, and Safety of [(14)C]ADC189 in Healthy Chinese Male Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06360796
• Other study ID #: 2023-ADC189-I-010
• Status: Recruiting
• Phase: Phase 1
• Start date: November 24, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: March 2024
• Source: Jiaxing AnDiCon Biotech Co.,Ltd
• Contact: Huan Zhou, PharmD
• Phone: +865523086046
• Email: zhouhuanbest[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to determined the metabolism, excretion, and substance balance of almonertinib of ADC189. The pharmacokinetic characteristics and safety profile of ADC189 was investigated following a single oral dose (45 mg/100 µCi) in healthy Chinese male participants.

Description:

This study adopted a single-center, open, non-randomized, single-dose design. Six to eight healthy Chinese male subjects were planned to be enrolled, and the final aim is to collect all required samples and data from at least 6 subjects.

After each subject take a single oral dose of 45 mg (about 100 μCi) [14C]ADC189 on Day 1, whole blood, plasma, urine and feces samples were collected at specified time points during the study. The total radioactivity was measured to calculate the ratio of total radioactivity of whole blood to total radioactivity of plasma, pharmacokinetic parameters, recovery rate and excretion pathway data of total radioactivity in whole blood and plasma. Meanwhile, the radioactive metabolite spectrum and structural identification of main metabolites in plasma, urine and feces were performed to obtain the pathway and characteristics of main metabolic elimination of ADC189 in human body, as well as circulating metabolites ≥10% of total radioactivity exposure in plasma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 1. healthy Chinese male subjects within 18 to 45 years old inclusive;

• 2. body weight over 50 Kg, and within a BMI range of 19.0 to 26.0 kg/m2 inclusive;

• 3. has no sperm donation plan, no family planning and voluntarily adopts strict contraceptive methods during the study period and within six months after the completion of the trial;

• 4. able to comprehend and willing to sign an Informed Consent Form (ICF).

Exclusion Criteria:

• 1. history or presence of an abnormal ECG;

• 2. participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in;

• 3. exposure to significant radiation within 12 months prior to Check-in;

• 4. participation in any other investigational study drug trial;

• 5. use of any prescription medications/products within 14 days prior to Check-in;

• 6. use of any drug that affects drug metabolism enzymes or transporters (P-gp and BCRP) in the 30 days prior to taking the study drug, as detailed in Appendix 5;

• 7. receipt of blood products within 1 month prior to Check-in.

Related Conditions & MeSH terms

• Metabolism
• Pharmacokinetics

Intervention

Drug:
• [(14)C]ADC189
Each subject take a single oral dose of about 45 mg (about 100 µCi) [(14)C]ADC189 on Day 1 of the study, and be observed by 504 hours.

Locations

Country	Name	City	State
China	The First Affilicated Hospital of Bengbu Medical University	Bengbu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Jiaxing AnDiCon Biotech Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Area Under the Curve (AUC) of [(14)C]ADC189 and its metabolites		504 hours
Primary	The Maximum Plasma Concentration [Cmax] of [(14)C]ADC189 and its metabolites		504 hours
Primary	The whole blood and serum concentrations of total radioactivity of [(14)C]ADC189 (about 100 µCi)		504 hours
Primary	The urinary and fecal recovery of total radioactivity of [(14)C]ADC189 (about 100 µCi)		504 hours