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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2024-09-22

Brief Summary

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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.

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Detailed Description

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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

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ADC189 tablet Group A

16 patients.

Group Type EXPERIMENTAL

ADC189 tablet

Intervention Type DRUG

ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study)

ADC189 granules

Intervention Type DRUG

ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study)

ADC189 granules Group B

16 patients.

Group Type EXPERIMENTAL

ADC189 tablet

Intervention Type DRUG

ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study)

ADC189 granules

Intervention Type DRUG

ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study)

ADC189 180mg Group

8 patients.

Group Type EXPERIMENTAL

ADC189 180mg

Intervention Type DRUG

ADC189 tablet, 180 mg, single oral dose. (Part 2 study)

Interventions

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ADC189 tablet

ADC189 tablet, 45 mg, single oral dose in each Group. (Part 1 study)

Intervention Type DRUG

ADC189 granules

ADC189 granules, 45 mg, single oral dose in each Group. (Part 1 study)

Intervention Type DRUG

ADC189 180mg

ADC189 tablet, 180 mg, single oral dose. (Part 2 study)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes