NCT05245396

Study Comparing Pharmacokinetics of Different Formulations of Evobrutinib in Healthy Participants

A Phase I, Single-site, Open-label, Partially Randomized Study to Evaluate the Relative Bioavailability and Pharmacokinetics of Evobrutinib Following Administration of Different Formulations in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetic (PK), pharmacodynamic (PD), and safety and tolerability of evobrutinib after oral administration of immediate release (IR) and modified release (MR) formulations in healthy participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ref (TF2)	Participants will receive 2 single oral doses of Ref (TF2) on Day 1 in treatment period 1, 2, or 3 of Part A, B, C and D.
DRUG	Evobrutinib MR-T1	Participants will receive single oral dose of MR-T1 on Day 1 in treatment period 1, 2, and 3 of Part A.
DRUG	Evobrutinib MR-T2	Participants will receive single oral dose of MR-T2 on Day 1 in treatment period 1, 2, and 3 of Part A.
DRUG	Evobrutinib MR-T3	Participants will receive single oral dose of MR-T3 on Day 1 in treatment period 1, 2, and 3 of Part A.
DRUG	Evobrutinib MR-T4	Participants will receive single oral dose of MR-T4 on Day 1 in treatment period 1, 2, and 3 of Part A.
DRUG	Evobrutinib MUPS-C1	Participants will receive single oral dose of MUPS-C1 on Day 1 in treatment period 1, 2, and 3 of Part B.
DRUG	Evobrutinib MUPS-C2	Participants will receive single oral dose of MUPS-C2 on Day 1 in treatment period 1, 2, and 3 of Part B.
DRUG	Evobrutinib MUPS-C3	Participants will receive single oral dose of MUPS-C3 on Day 1 in treatment period 1, 2, and 3 of Part C.
DRUG	Evobrutinib MUPS-C4	Participants will receive single oral dose of MUPS-C4 on Day 1 in treatment period 1, 2, and 3 of Part C.
DRUG	Evobrutinib MR-T adapated	Participants will receive single oral dose of MR-T adapted on Day 1 in treatment period 1, 2, and 3 of Part D.

Timeline

• Start date: 2022-02-02
• Primary completion: 2023-02-14
• Completion: 2023-02-14
• First posted: 2022-02-18
• Last updated: 2023-03-22

Locations

1 site across 1 country: United Kingdom