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Effects of Cladribine Tablets on the PK of Microgynon®

Primary Purpose

Relapsing Multiple Sclerosis (RMS)

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Cladribine

Placebo

Microgynon®

About this trial

This is an interventional other trial for Relapsing Multiple Sclerosis (RMS) focused on measuring Multiple Sclerosis, Cladribine, Microgynon®

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

St. Josef und St. Elisabeth Hospital gGmbH
Nuvisan GmbH
M.A. - LEK A.M.Maciejowscy SC.
BioResearch Group Sp. z o. o
IKARDIA Hospital Cardiology
BioVirtus Research Site Sp
MTZ Clinical Research Sp. z o.o.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

First Cladribine, Then Placebo

First Placebo, Then Cladribine

Arm Description

Participants will receive 5-day once-daily cladribine treatment along with Microgynon® tablet once daily from Day 1 to Day 21 in period 1 followed by 5-day once daily cladribine matched placebo treatment along with Microgynon® tablet once daily from Day 1 to Day 21 in period 2.

Participants 5-day once daily cladribine matched placebo treatment along with Microgynon® tablet once daily from Day 1 to Day 21 in period 1 followed by will receive 5-day once-daily cladribine treatment along with Microgynon® tablet once daily from Day 1 to Day 21 in period 2.

Outcomes

Primary Outcome Measures

Area Under Plasma Concentration Time Curve From Zero to Tau at Steady State (AUCtau,ss) of Ethinyl Estradiol and Levonorgestrel

Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Ethinyl Estradiol and Levonorgestrel

Secondary Outcome Measures

Minimum Observed Plasma Concentration From Time Zero to Tau at Steady State (Cmin,ss) of Ethinyl Estradiol and Levonorgestrel

Plasma Concentration at End of Dosing Interval at Steady State (Ctrough) of Ethinyl Estradiol and Levonorgestrel

Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of Ethinyl Estradiol and Levonorgestrel

Average Plasma Concentration at Steady State (Cave,ss) of Ethinyl Estradiol and Levonorgestrel

Peak-to-Trough Fluctuation Over One Complete Dosing Interval at Steady State of Ethinyl Estradiol and Levonorgestrel

Maximum Observed Plasma Concentration (Cmax) of Cladribine

Time to Reach Maximum Observed Plasma Concentration (tmax) of Cladribine

Occurrence of Participants With Treatment Emergent Adverse Events (TEAEs)

Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Electrocardiogram (ECG) and Laboratory Findings

Number of participants with clinically significant abnormalities will be reported.

Full Information

NCT ID

NCT03745144

First Posted

November 14, 2018

Last Updated

October 21, 2022

Sponsor

Merck KGaA, Darmstadt, Germany

1. Study Identification

Unique Protocol Identification Number

NCT03745144

Brief Title

Effects of Cladribine Tablets on the PK of Microgynon®

Official Title

A Randomized, Double-blind, 2-Period, 2-Sequence Crossover Phase I Study With a 1 Month run-in Period to Examine the Effect of Cladribine Tablets on the PK of a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel (Microgynon®) in Pre-Menopausal Women With RMS

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

January 17, 2019 (Actual)

Primary Completion Date

September 2, 2022 (Actual)

Study Completion Date

September 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing Multiple Sclerosis (RMS)

Keywords

Multiple Sclerosis, Cladribine, Microgynon®

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

First Cladribine, Then Placebo

Arm Type

Experimental

Arm Description

Arm Title

First Placebo, Then Cladribine

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cladribine

Intervention Description

Participants will receive cladribine once-daily for 5 consecutive days in treatment period 1 and 2.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will receive placebo matched to cladribine once-daily for 5 consecutive days in treatment period 1 and 2.

Intervention Type

Drug

Intervention Name(s)

Microgynon®

Intervention Description

Participants will receive Microgynon® tablet once daily for 21 days in treatment period 1 and 2.

Primary Outcome Measure Information:

Title

Area Under Plasma Concentration Time Curve From Zero to Tau at Steady State (AUCtau,ss) of Ethinyl Estradiol and Levonorgestrel

Time Frame