Overview

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