Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Xevinapant (Debio 1143)
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 an investigational small molecule drug developed by Merck KGaA. It is also known as Debio 1143. Clinical work to date has focused on pharmacokinetic evaluation in healthy volunteers rather than in a specific patient population.
Xevinapant is developed by Merck KGaA, which trades under the ticker MKGAF. The compound is also referred to as Debio 1143, a name that reflects its earlier development history.
Yes. Xevinapant and Debio 1143 are two names for the same investigational compound. Searches using either name refer to the same small molecule being developed by Merck KGaA.
Xevinapant is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The recorded Phase 1 activity consists of a completed pharmacokinetic study in healthy volunteers.
Xevinapant has been studied in the Phase 1 trial NCT05519540, titled a PK Study of Xevinapant (Debio 1143) in Healthy East Asian Participants. That trial was completed, enrolled 24 healthy volunteers, and was conducted in the United Kingdom.
NCT05519540 evaluated the pharmacokinetics of Xevinapant, also called Debio 1143, in healthy East Asian participants. The completed Phase 1 study enrolled 24 healthy volunteers of any sex, aged 18 years and older, and was run in the United Kingdom.