Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Xevinapant · 1 trial · 1 indication
The area under the concentration-time curve (AUC) from time zero (= dosing time) to the last sampling time (tlast) at which the concentration is at or above the lower limit of quantification. Calculated using the mixed log-linear trapezoidal rule (linear up, log down).
The AUC from time zero (dosing time) extrapolated to infinity, based on the predicted value for the concentration at t last , as estimated using the linear regression from Terminal first order (elimination) rate constant (Lambda z) determination. AUC0-inf = AUC0-t plus Clast pred/lambda z. Lambda Z was terminal elimination rate constant determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.
Cmax was obtained directly from concentration versus time curve.
| Arm | Type | Description |
|---|---|---|
| Group 1: Japanese Participants: Xevinapant (Debio 1143) | EXPERIMENTAL | Xevinapant (Debio 1143) was administered in Healthy Japnaese participants at a dose of 200 milligrams (mg), orally under fasted conditions. |
| Group 2: Non-Japanese East Asian Participants: Xevinapant (Debio 1143) | EXPERIMENTAL | Xevinapant (Debio 1143) was administered in Healthy Non- Japanese participants at a dose of 200 mg, orally under fasted conditions. |
| Name | Type | Description |
|---|---|---|
| Xevinapant (Debio 1143) | DRUG | All participants (Japanese and non-Japanese) received a single oral dose of 200mg xevinapant (Debio 1143) on Day 1 under fasted condition. |
Inclusion Criteria: * Healthy participant of Japanese or other East Asian origin. Group 1: Japanese participants must be first generation (born in Japan) with both biological parents and all 4 biological grandparents being Japanese native born, lived for less than (\<)10 years outside of Japan, and...
Xevinapant is a small molecule drug being developed by Merck KGaA. It is currently in Phase 1 clinical development. The drug has been studied in a clinical trial involving healthy participants, with the trial focusing on pharmacokinetics.
Xevinapant is being studied for use in healthy participants. The completed Phase 1 trial, NCT05519540, was a pharmacokinetic study of Xevinapant in healthy East Asian participants. It is not approved for any disease indication.
Xevinapant is being developed by Merck KGaA, a company with the ticker MKGAF. The drug is currently in Phase 1 clinical development.
Xevinapant is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers.
Xevinapant has one completed clinical trial, NCT05519540, titled 'PK Study of Xevinapant (Debio 1143) in Healthy East Asian Participants.' This Phase 1 trial enrolled 24 participants in the United Kingdom and was a controlled study.
Yes, Xevinapant is also known as Debio 1143. The clinical trial NCT05519540 refers to the drug as 'Xevinapant (Debio 1143),' indicating that both names refer to the same drug.