Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive

Phase 1 Completed 20 enrolled Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

NaSingle-groupOpen-labelOther

Summary

The purpose of this study was to assess the effect of M2951 on the pharmacokinetics (PK) of a combined oral contraceptive \[Ethinyl estradiol/Norethisterone (EE/NET)\] in healthy female participants. * Study Duration: up to 46 days * Treatment Duration: Days 4 to 17 (14 days treatment with M2951); Days 1 and 15 (2 days treatment with Combined Oral Contraceptive \[COC\]) * Visit Frequency: Participants were resident in the Clinical Research Unit from Day -1 to Day 18.

Timeline

Start: 2022-08-24
Primary completion: 2022-11-25
Completion: 2022-11-25

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evobruitnib	Unknown	45 mg	Oral
Subject	Norethindrone	Unknown	0.5 mg	Oral
Subject	ethinyl estradiol	Small molecule	0.03 mg	Oral

Indications

No indication recorded.