Study Comparing Pharmacokinetics of Different Formulations of Evobrutinib in Healthy Participants

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

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.

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany

  collaborator INDUSTRY

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

  lead INDUSTRY

Principal Investigators

• Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-02-02

Primary Completion

2023-02-14

Completion

2023-02-14

Countries

• United Kingdom

Study Locations