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

NCT06360796 | Completed Phase 1

• 1 other identifier: 2023-ADC189-I-010
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacokinetics; Metabolism

Outcome Measures

Primary Outcomes (4)

• The Area Under the Curve (AUC) of [(14)C]ADC189 and its metabolites

  504 hours

• The Maximum Plasma Concentration [Cmax] of [(14)C]ADC189 and its metabolites

  504 hours

• The whole blood and serum concentrations of total radioactivity of [(14)C]ADC189 (about 100 μCi)

  504 hours

• The urinary and fecal recovery of total radioactivity of [(14)C]ADC189 (about 100 μCi)

  504 hours

Study Arms (1)

ADC189

EXPERIMENTAL

45 mg (about 100 μCi) \[(14)C\]ADC189

Drug: [(14)C]ADC189

Interventions

[(14)C]ADC189 DRUG

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.

ADC189

Eligibility Criteria

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

You may qualify if:

• \. healthy Chinese male subjects within 18 to 45 years old inclusive;
• \. body weight over 50 Kg, and within a BMI range of 19.0 to 26.0 kg/m2 inclusive;
• \. 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;
• \. able to comprehend and willing to sign an Informed Consent Form (ICF).

You may not qualify if:

• \. history or presence of an abnormal ECG;
• \. participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in;
• \. exposure to significant radiation within 12 months prior to Check-in;
• \. participation in any other investigational study drug trial;
• \. use of any prescription medications/products within 14 days prior to Check-in;
• \. 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;
• \. receipt of blood products within 1 month prior to Check-in.

Sponsors & Collaborators

• Jiaxing AnDiCon Biotech Co.,Ltd: lead

Study Sites (1)

The First Affilicated Hospital of Bengbu Medical University

Bengbu, Anhui, 233004, 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 3, 2024
• First Posted: April 11, 2024
• Study Start: November 24, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: January 20, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)