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This is a randomized, open, parallel, single center phase I clinical trial to evaluate the impact of food on the pharmacokinetics of TQB3454 tablets in healthy adult subjects. The aim is to evaluate the impact of food on the pharmacokinetics as well as the safety after single dose of TQB3454 tablets taken orally by Chinese healthy adult subjects, with pharmacokinetic indicators as the primary endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3454 tablets under fast condition | Experimental | TQB3454 tablets 600mg, take one dose orally under fast condition. |
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| TQB3454 tablets under fed condition | Experimental | TQB3454 tablets 600mg, take one dose orally under fed condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3454 tablets | Drug | TQB3454 is a Isocitrate dehydrogenase 1 (IDH1) mutation inhibitor. |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | Maximum plasma drug concentration | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose. |
| Area under the time-concentration curve from 0 to t hours (AUC0-t) | Area under the plasma concentration-time curve from the time of first dose to the time of the last measurable concentration. | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose. |
| Area under the time-concentration curve from 0 to infinity (AUC0-∞) | Area under the plasma concentration-time curve from the time of first dose extrapolated to infinity | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose. |
| Time to peak (Tmax) | Time to reach maximum plasma concentration after drug administration | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose. |
| Elimination half-life (t1/2) | The time it takes for the blood concentration of a drug to decrease from its highest value to half in the body. | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose. |
| Apparent volume of distribution (Vd/F) | The ratio of the amount of drug in the body to the concentration in the blood. | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rate | The incidence of adverse events (AEs), abnormal laboratory test values, and severe adverse events (SAEs). | Before the first administration to 360 hours after the last administration. |
| Adverse event severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Cao, Master of Medicine | Contact | 18661809090 | caoyu1767@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 400010 | China |
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| Apparent clearance (CL/F) |
Apparent total clearance of the drug from plasma after oral administration. |
| pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose. |
| Elimination rate constant (λz) | Terminal disposition rate constant/terminal rate constant | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose. |
| Lag time (tlag) | The time required from the start of administration to the appearance of the drug in the blood. | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose. |
| Percentage of residual area (AUC% Extrap) | Residual area as a percentage of the entire area under curve. | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 264, 330 hours after dose. |
The severity of adverse events (AEs), abnormal laboratory test values, and severe adverse events (SAEs).
| Before the first administration to 360 hours after the last administration. |