NCT02085863
Completed
Phase 1
A Randomized, Double-Blind, Placebo-Controlled, Two-way Crossover Drug-drug Interaction Study to Assess the Effect of Laquinimod 0.6 mg on the Pharmacokinetics and Pharmacodynamics of Ethinylestradiol and Levonorgestrel in Healthy Young Women
Overview
- Phase
- Phase 1
- Intervention
- laquinimod
- Conditions
- Pharmacokinetics
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- AUC0-24 of EE and LNG plasma concentrations.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a single center, randomized, double blind, placebo controlled, 2-way crossover drug-drug interaction (DDI) study to assess the effect of laquinimod on the PK and PD of ethinylestradiol (EE) and levonorgestrel (LNG) a commonly used oral contraceptive combination.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pre-menopausal women of age 18 to 40 years, who are healthy, non-pregnant and not planning pregnancy within the study period.
- •Women of childbearing potential who are willing to continuously use the oral contraceptive (OC) product containing EE 30 μg and LNG 150 μg from at least the commencement of their last normal period prior to the first dose of study medication and for a total of 4 consecutive cycles.
- •Willing to use a double barrier method of contraception (condom or diaphragm with spermicide) from screening until 30 days after the last laquinimod/placebo treatment. During administration of OC, the double barrier method should also be used.
- •Body Mass Index ranging from 18-30 kg/m2, inclusive.
- •Must be in a good health as determined by medical history, electrocardiogram (ECG), vital signs, physical and gynecological examination, and clinical laboratory tests.
- •Must have a regular menstrual cycle of 25 to 35 days (28-3/+7days) in the preceding 3 months prior to screening.
- •Subjects must be able to understand the requirements of the study and be willing to comply with the requirements of the study (eg, all dietary, exercise, tobacco and alcohol restrictions) and provide their written informed consent to participate in the study.
Exclusion Criteria
- •Subjects who smoke at any frequency, have smoked in the last 6 months, or are planning to start smoking during the study, tobacco users, subjects currently using nicotine products (patches, gums, etc.) or subjects with a positive urine cotinine test at screening and/or at day -
- •Subjects with a known drug hypersensitivity to laquinimod, or one of its excipients (ie, mannitol, meglumine, or sodium stearyl fumarate).
- •Subjects with any significant food/drug allergies at the discretion of the investigator.
- •Subjects who are pregnant or lactating.
- •Subjects who had one of the following conditions in the noted amount of time prior to screening or at any time between screening and day -7: o Major trauma or surgery in the past 2 months.
- •Acute infection within 2 weeks (14 days).
- •Any malignancies, excluding basal cell carcinoma, prior to randomization.
- •Subjects who have any condition that possibly interferes with drug absorption, distribution, metabolism, or excretion.
- •Subjects suffering from, or with history of, one of the following: cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s), or a history of any illness that, in the opinion of the Investigator, might pose additional risk to the subject by participation in the study or confound the results of the study.
- •Subjects suffering from any condition in which the OC is contra indicated or not recommended.
Arms & Interventions
Laquinimod
once daily oral doses of laquinimod (with combination oral contraceptives)
Intervention: laquinimod
Laquinimod
once daily oral doses of laquinimod (with combination oral contraceptives)
Intervention: Placebo
Placebo
Matching placebo (with combination oral contraceptives)
Intervention: laquinimod
Placebo
Matching placebo (with combination oral contraceptives)
Intervention: Placebo
Outcomes
Primary Outcomes
AUC0-24 of EE and LNG plasma concentrations.
Time Frame: 10 min prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose
to assess the effect of once daily oral doses of laquinimod on the pharmacokinetics (PK) of ethinylestradiol (EE) and levonorgestrel (LNG)
Cmax of EE and LNG plasma concentrations.
Time Frame: 10 min prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose
to assess the effect of once daily oral doses of laquinimod on the pharmacokinetics (PK) of ethinylestradiol (EE) and levonorgestrel (LNG
Secondary Outcomes
- Ctrough of luteinizing hormone [LH], and follicle-stimulating hormone [FSH](10 min prior to dosing)
- CL/F of EE and LNG plasma concentrations(10 min prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose)
- AUC0-24 of progesterone(10 min prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose)
- Summary of Participants with Adverse Events(25 Weeks)
- AUC0-24 of laquinimod plasma concentrations(10 min prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose)
- Cmax of laquinimod plasma concentrations(10 min prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose)
- V/F of EE and LNG plasma concentrations(10 min prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose)
- Cmax of progesterone(10 min prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose)
- Tmax of EE and LNG plasma concentrations(10 min prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose)
- T1/2 of EE and LNG plasma concentrations(10 min prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose)
- Tmax of laquinimod plasma concentrations(10 min prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose)
Study Sites (1)
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