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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06428903
• Other study ID #: ADC-DNXV-189-GR
• Status: Recruiting
• Phase: Phase 1
• Start date: March 12, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Jiaxing AnDiCon Biotech Co.,Ltd
• Contact: Zhao Wei
• Phone: 0531-89268212
• Email: zhao4wei2[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 31, 2024
• Est. primary completion date: July 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 1. Healthy male subjects aged 18-45 years old

• 2. Male subjects weight over 50 kg

Exclusion Criteria:

• 1. Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions

• 2. Have a history of drug abuse in the past five years or use drugs in the three months prior to screening

• 3. Blood donation or blood loss > 400 mL in 3 months before screening

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• ADC189 tablet
ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study)
• ADC189 granules
ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study)
• ADC189 180mg
ADC189 tablet, 180 mg, single oral dose. (Part 2 study)

Locations

Country	Name	City	State
China	Zhao Wei	Jinan	Shang Dong

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	ADC189 Granules	ADC189 plasma exposure, area under the concentration-time curve	15 days
Primary	ADC189 Tablet	ADC189 plasma exposure, area under the concentration-time curve	15 days
Primary	ADC189 Ultra high dose	Single dose of 180mg ADC189 tablet plasma exposure, area under the concentration-time curve	15 days