NCT06428903

Comparative Bioavailability Study of Tablet and Granule Formulations of ADC189 and the Study of Ultra-high Dose

A Comparison Study of ADC189 Bioavailability Between Tablet and Granule in Healthy Chinese Adult Male Subjects, and the Safety and Pharmacokinetics of Ultra-high Dose ADC189

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Part 1 of this study will compare the pharmacokinetic performance of tablet and granule formulations of ADC189 under fasted conditions in healthy volunteers. A randomized, two-period, two-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation without food. The purpose of Part 2 study is to determine the safety and pharmacokinetics of ultra high dose of ADC189 in healthy subjects.

Detailed description

In Part 1 study, a total of 32 subjects were randomly divided into two groups, A and B, with 16 subjects in each group. After a 28-day screening period, on the first day of Period 1 (D1), subjects in group A took ADC189 granules (a single oral dose, 45mg), and subjects in group B took ADC189 tablets (a single oral dose, 45mg), all subjects were under fasted conditon. In Period 2, two groups will change to the fomulation which is different in Period 1 respectively, and all the steps will keep the same as Period 1. Each period lasts for 15 days, and have a 7-day interval between 2 periods. Blood samples will be taken, pharmacokinetic and saftey profiles will be observed. In Part 2 study, the ultra high dose of ADC189 (a single oral dose, 180mg) will applied in 8 healty adult male subjects. The pharmacokinetic and saftey profiles will be observed during the following 15 days, and blood sample will be taken.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	ADC189 tablet	ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study)
DRUG	ADC189 granules	ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study)
DRUG	ADC189 180mg	ADC189 tablet, 180 mg, single oral dose. (Part 2 study)

Timeline

• Start date: 2024-03-12
• Primary completion: 2024-09-22
• Completion: 2024-09-22
• First posted: 2024-05-24
• Last updated: 2025-01-20

Locations

1 site across 1 country: China