Effects of Cladribine Tablets on the Pharmacokinetics of Microgynon®

Last updated: N/A
Sponsor: Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Overall Status: Active - Recruiting

Phase

1

Condition

Neurologic Disorders

Memory Loss

Multiple Sclerosis

Treatment

N/A

Clinical Study ID

NCT04086225
MS700568_0031
2018-001015-70
  • Ages 18-45
  • Female

Study Summary

The purpose of this study is to investigate the potential effects of cladribine on the pharmacokinetics of monophasic oral contraceptive microgynon® by assessment of its constituents, ethinyl estradiol (EE) and levonorgestrel (LNG).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Are pre-menopausal women with or without child-bearing potential with a negative serumpregnancy test, and women with child-bearing potential receiving adequate birthcontrol

  • Participants with diagnosis of clinically stable and definite relapsing multiplesclerosis (RMS)

  • Adequate hematological, hepatic and renal function as defined in the protocol

  • Are able and willing to accept dietary restrictions and restrictions regarding the useof concomitant medications (including over-the-counter products, herbal medicines anddietary supplements) over the course of the study

  • Have a body weight and body mass index (BMI) within the range at screening

  • Other protocol defined inclusion criteria could apply

Exclusion

Exclusion Criteria:

  • History of clinically relevant allergy or known hypersensitivity to the activesubstance or to any of the excipients of cladribine tablets or hypersensitivity todrugs with a similar chemical structure to cladribine - History of clinically relevantallergy or known hypersensitivity to 1 of the active substances levonorgestrel (LNG)or ethinylestradiol (EE) or to any excipients of Microgynon® tablets

  • Positive results from serology examination for Hepatitis B surface antigen (HbsAg) notdue to vaccination, hepatitis B core antibody (HbcAb), Hepatitis C virus antibody (anti- HCV) or Human Immunodeficiency antibody (anti-HIV)

  • Presence or risk of venous thromboembolism (VTE) arterial thromboembolism (ATE)

  • Diabetes mellitus (Type 1 or Type 2) with vascular manifestations

  • Signs or symptoms of neurological disease other than multiple sclerosis (MS) thatcould explain the symptoms of the participant

  • Presence of gastrointestinal (GI) disease or history of gastrointestinal -tractsurgery

  • Exposure to another investigational drug within the last 2 months or within last 6month if agent is known to be immunosuppressive

  • Other protocol defined exclusion criteria could apply

Study Design

Total Participants: 34
Study Start date:
January 17, 2019
Estimated Completion Date:
April 06, 2020

Connect with a study center

  • St. Josef und St. Elisabeth Hospital gGmbH

    Bochum, 44791
    Germany

    Active - Recruiting

  • Please Contact the Merck KGaA Communication Center

    Darmstadt, 64293
    Germany

    Active - Recruiting

  • Nuvisan GmbH

    Neu-Ulm, 89231
    Germany

    Active - Recruiting

  • Fachklinik für Neurologie Dietenbronn GmbH - Diagnostisches und therapeutisches Kompetenzzentrum für Multiple Sklerose

    Ulm, 89081
    Germany

    Active - Recruiting

  • NeuroPoint

    Ulm, 89073
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm (11785)

    Ulm, 89081
    Germany

    Active - Recruiting

  • BioVirtus Research Site Sp (13013)

    Otwock, 04-749
    Poland

    Active - Recruiting

  • MTZ Clinical Research Sp. z o.o.

    Warszawa, 02-106
    Poland

    Active - Recruiting

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