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| Name | Class |
|---|---|
| AnHeart Therapeutics Inc. | INDUSTRY |
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This is a single-center, open-label, fixed sequence phase I clinical study. To evaluate the effect of continuous administration of omeprazole magnesium enteric coated tablets on PK after single dose AB-106 capsule administration in Chinese healthy male subjects. This study includes a screening period (1-28 days before administration), treatment period (34 days), and follow-up period ( after the last dose completed 7 ± 3 days). The treatment period of this study was divided into two periods, and the subjects were divided into two groups, 12 subjects in the first group and 10 subjects in the second group. The treatment method and research process of each group of subjects are the same. After the first group of subjects completes the second cycle and is evaluated by the investigator and sponsor, the second group of subjects can start administration. If there are no more than 4 subjects in the first group who have vomiting gastrointestinal reaction (vomiting occurs within 8 hours after each cycle of administration) after completing the two cycles of administration of AB-106 400 mg, they can be added to the second group of subjects, and the number of added subjects shall not exceed the number of subjects who have vomiting gastrointestinal reaction. If more than 4 subjects have gastrointestinal reaction of vomiting, the investigator and sponsor will make a comprehensive evaluation, and can reduce the dosage of AB-106 to 200 mg, and 22 subjects will be included in the trial at one time or supplemented in the second group to complete the 400 mg dose group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omeprazole combined with AB-106 group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple administration of omeprazole Single administration of AB-106 | Drug | Take AB-106 capsule 400 mg orally on an empty stomach in the morning of the first day of the first cycle Take omeprazole magnesium enteric coated tablets 40mg once a day, 30 minutes before breakfast on days 1-4 of the second cycle. On the morning of the fifth day of the second cycle, the subjects will take omeprazole magnesium enteric coated tablets 40 mg, and AB-106 capsules 400 mg after an interval of 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | plasma drug peak concentration | Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days |
| AUClast | area under the plasma drug concentration time curve from 0 to the last measurable drug concentration time point | Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days |
| AUCinf | Area under the plasma drug concentration time curve from 0 to infinity (if it can be calculated reliably) | Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to reach plasma drug peak concentration | Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days |
| λ z | Elimination rate constant |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | China |
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| Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days |
| t1/2 | elimination half-life | Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days |
| CL/F | Apparent clearance | Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days |
| Vz/F | apparent distribution volume | Day 1 to day15 for both treatment cycle one and cycle two, the total duration is 30 days |
| Number of adverse events as assessed by CTCAE 5.0 | Number of participants with treatment-related or not-related adverse events as assessed by CTCAE v5.0 | Screening period (1-28 days before treatment), treatment period (34 days) and follow-up period (7 ± 3 days after the last visit). The total duration is about 69 days. |