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...
Evobruitnib is an investigational small molecule drug being developed by Merck KGaA. It is in Phase 1 clinical development, and the specific disease indications it is intended to treat have not been disclosed. It is not approved for any use.
Evobruitnib is being developed by Merck KGaA, which trades under the ticker MKGAF. The company is the sponsor of the clinical program evaluating the drug.
Evobruitnib is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. One Phase 1 trial has been completed.
Evobruitnib has been studied in one completed Phase 1 trial, NCT07215806, titled Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive. The trial enrolled 20 healthy female participants in Germany and was an uncontrolled study with no randomization or blinding.
NCT07215806 was a Phase 1 drug interaction study evaluating the effect of Evobruitnib on the pharmacokinetics of a combined oral contraceptive. It enrolled 20 healthy female volunteers aged 18 years and older in Germany. The trial was uncontrolled and has been completed.