Effects of Cladribine Tablets on the PK of Microgynon®

• Status: Recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany; Merck KGaA, Darmstadt, Germany
• Treatments: Cladribine; Ethinyl Estradiol-Norgestrel Combination; Ethinyl estradiol, levonorgestrel drug combination

Criteria

Inclusion Criteria:

• Are pre-menopausal women with or without child-bearing potential with a negative serum pregnancy test, and women with child-bearing potential receiving adequate birth control

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

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

• Are able and willing to accept dietary restrictions and restrictions regarding the use of concomitant medications (including over-the-counter products, herbal medicines and dietary 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 Criteria:

• History of clinically relevant allergy or known hypersensitivity to the active substance or to any of the excipients of cladribine tablets or hypersensitivity to drugs with a similar chemical structure to cladribine - History of clinically relevant allergy 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) not due 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) that could explain the symptoms of the participant

• Presence of gastrointestinal (GI) disease or history of gastrointestinal -tract surgery

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

• Other protocol defined exclusion criteria could apply