Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Evobruitnib · 1 trial · 1 indication
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above the Lower Limit of quantification (LLOQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured serum concentrations of the terminal log-linear phase.
Cmax was obtained directly from the concentration versus time curve.
| Arm | Type | Description |
|---|---|---|
| COC + Evobrutinib | EXPERIMENTAL | Participants received combined oral contraceptive (COC) \[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\], 0.5 mg of Norethisterone (NET)\] orally on Day 1 and 15 in combination with Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17. |
| Name | Type | Description |
|---|---|---|
| Evobruitnib | DRUG | Participants received Evobruitnib at a dose of 45 mg orally twice daily on Days 4 to 17. |
| Combined oral contraceptive [ethinyl estradiol/ norethisterone (EE/NET)] | DRUG | Participants received combined oral contraceptive (COC) \[0.03 milligrams (mg) of Ethinyl Estradiol (EE)\], 0.5 mg of Norethisterone (NET)\] orally on Day 1 and 15. |
Inclusion Criteria: * Participants are overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a ri...
Evobrutinib is an investigational small molecule being developed by Merck KGaA (ticker: MKGAF). It is currently in Phase 1 clinical development. The drug has been studied in a completed clinical trial involving healthy female participants.
Evobrutinib is being studied for its effect on the pharmacokinetics of a combined oral contraceptive in healthy participants. The completed Phase 1 trial enrolled 20 healthy female subjects to evaluate this drug interaction. It is not approved for any indication and remains investigational.
Evobrutinib is being developed by Merck KGaA, a science and technology company. The company's stock is traded under the ticker MKGAF. Merck KGaA is conducting clinical research on this investigational small molecule drug.
Evobrutinib is in Phase 1 clinical development. The drug has completed one Phase 1 trial, which was an uncontrolled, open-label study. It is not FDA approved and remains an investigational agent under clinical investigation.
Evobrutinib has one completed clinical trial registered as NCT07215806. This Phase 1 study, titled "Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive," enrolled 20 healthy female participants in Germany. The trial was not randomized or double-blinded.