Clinical trial NCT06360796: Study of Pharmacokinetics and Metabolism on [(14)C]ADC189
Official title: A Phase I Study to Investigate the Absorption, Metabolism, Excretion, and Safety of [(14)C]ADC189 in Healthy Chinese Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Metabolism
Lead sponsor: Jiaxing AnDiCon Biotech Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-04-11
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Area Under the Curve (AUC) of [(14)C]ADC189 and its metabolites
timeFrame: 504 hours
measure: The Maximum Plasma Concentration [Cmax] of [(14)C]ADC189 and its metabolites
timeFrame: 504 hours
measure: The whole blood and serum concentrations of total radioactivity of [(14)C]ADC189 (about 100 μCi)
timeFrame: 504 hours
measure: The urinary and fecal recovery of total radioactivity of [(14)C]ADC189 (about 100 μCi)
timeFrame: 504 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affilicated Hospital of Bengbu Medical University
state: Anhui
Study officials:
References: