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OpenTrials
Completed

NCT Number: NCT05245396

Study Comparing Pharmacokinetics of Different Formulations of Evobrutinib in Healthy Participants

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical Ltd

Nottingham, NG11, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants are overtly healthy as determined by medical evaluation, including comprehensive clinical assessment (detailed medical history and a complete physical examination), ECG, and laboratory investigations (hematology and biochemistry)
  • Participants have a body weight within 50.0 to 100.0 kilogram (kg) and body mass index (BMI) within the range 19 to 32 kilogram per meter square (kg/m^2) (inclusive)
  • Other protocol defined inclusion criteria could apply

Exclusion criteria

  • Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, metabolic, hematological, lymphatic, neurological (including epilepsy), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as determined by medical evaluation
  • Participants with history of any malignancy
  • Administration of live vaccines or live-attenuated virus vaccines within 3 months prior to Screening. Administration of other types of vaccines (e.g. SARS-CoV-2 vaccines) is allowed until 2 weeks before the admission to the CRU
  • Medical history and physical examination results that include any ongoing clinically relevant findings as judged by the Investigator
  • Moderate or strong inhibitors or inducers of CYP3A4/5 or Pgp within 4 weeks prior to the first administration of study intervention
  • Other protocol-defined exclusion criteria could apply

Treatment and study plan

Ref (TF2)

Drug

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.

Other names: M2951

Evobrutinib MR-T1

Drug

Participants will receive single oral dose of MR-T1 on Day 1 in treatment period 1, 2, and 3 of Part A.

Other names: M2951

Evobrutinib MR-T2

Drug

Participants will receive single oral dose of MR-T2 on Day 1 in treatment period 1, 2, and 3 of Part A.

Other names: M2951

Evobrutinib MR-T3

Drug

Participants will receive single oral dose of MR-T3 on Day 1 in treatment period 1, 2, and 3 of Part A.

Other names: M2951

Evobrutinib MR-T4

Drug

Participants will receive single oral dose of MR-T4 on Day 1 in treatment period 1, 2, and 3 of Part A.

Other names: M2951

Evobrutinib MUPS-C1

Drug

Participants will receive single oral dose of MUPS-C1 on Day 1 in treatment period 1, 2, and 3 of Part B.

Other names: M2951

Evobrutinib MUPS-C2

Drug

Participants will receive single oral dose of MUPS-C2 on Day 1 in treatment period 1, 2, and 3 of Part B.

Other names: M2951

Evobrutinib MUPS-C3

Drug

Participants will receive single oral dose of MUPS-C3 on Day 1 in treatment period 1, 2, and 3 of Part C.

Other names: M2951

Evobrutinib MUPS-C4

Drug

Participants will receive single oral dose of MUPS-C4 on Day 1 in treatment period 1, 2, and 3 of Part C.

Other names: M2951

Evobrutinib MR-T adapated

Drug

Participants will receive single oral dose of MR-T adapted on Day 1 in treatment period 1, 2, and 3 of Part D.

Other names: M2951

Primary outcomes

  1. Relative Bioavailability Based on Area Under the Plasma Concentration Curve From Time Zero to 24 Hours Post Dose [Frel(AUC0-24)] of Evobrutinib Modified-Release Formulation Compared to Immediate-Release Evobrutinib Reference Formulation

    Time frame: Pre-dose up to 72 hours post-dose on Day 4

  2. Relative Bioavailability Based on Area Under the Plasma Concentration Curve From Time Zero to Infinity [Frel(AUC0-inf)] of Evobrutinib Modified-Release Formulation Compared to Immediate-Release Evobrutinib Reference Formulation

    Time frame: Pre-dose up to 72 hours post-dose on Day 4

Secondary outcomes

  1. Number of Participants with Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Abnormal Laboratory Test Results, Abnormal Vital Signs and Abnormal Electrocardiogram (ECG) Measurements

    Time frame: Up to Day 123

  2. Pharmacokinetic Plasma Concentration of Evobrutinib Formulations

    Time frame: Pre-dose up to 72 hours post-dose on Day 4

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • Merck KGaA, Darmstadt, Germany

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2022
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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