C5041053 - A PHASE 1 MULTIPLE-DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF ETRASIMOD IN HEALTHY LACTATING WOMEN

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520930-44-00

Acronym

C5041053

Enrollment

Registered

2025-05-07

Start date

2025-07-18

Completion date

Unknown

Last updated

2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis and immune-mediated inflammatory disorders

Brief summary

Breast milk etrasimod PK parameters: AUCtau, Cmax, Aebm, Aebm%, Tmax, and CLbm (if data permit).

Detailed description

Plasma etrasimod PK parameters: AUCtau, Cmax, Tmax, as data permits., MPAUCtau, TEAEs, clinical laboratory tests, vital signs, and ECGs, BWNID, BWNMD, and BWNIDPCM

Interventions

DRUGEtrasimod Arginine Blue

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Breast milk etrasimod PK parameters: AUCtau, Cmax, Aebm, Aebm%, Tmax, and CLbm (if data permit).	—

Secondary

Measure	Time frame
Plasma etrasimod PK parameters: AUCtau, Cmax, Tmax, as data permits., MPAUCtau, TEAEs, clinical laboratory tests, vital signs, and ECGs, BWNID, BWNMD, and BWNIDPCM	—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026