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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pharmacokinetics; Metabolism
• Intervention / Treatment: Drug: [(14)C]ADC189

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Huan Zhou, PharmD; Phone Number: +865523086046; Email: zhouhuanbest@vip.163.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • Recruiting
      • The First Affilicated Hospital of Bengbu Medical University
      • Contact: Huan Zhou; Phone Number: +8613665527160; Email: zhouhuanbest@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADC189; 45 mg (about 100 μCi) [(14)C]ADC189	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-ADC189-I-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No