PharmacokineticsPhase 1NCT02085863
A Phase I Study in Young Healthy Women to Investigate the Effects of Laquinimod on Standard Oral Contraceptive When Both Treatments Are Given Together
A Phase 1 study testing laquinimod in people with Pharmacokinetics and Pharmacodynamics, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Pharmacodynamics
- What is being tested?
- laquinimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Nov 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 -7.
- 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).
Show all 28Show fewer
- 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.
- Subjects who have used patches/intrauterine device/injectable hormonal contraception within 6 month prior to screening.
- History of irregular menstruation.
- Subjects with clinically relevant abnormality (judged by the investigator) of serum electrolytes or complete blood count.
- Serum levels of ≥2× upper limit of normal alanine aminotransferase or aspartate aminotransferase or gamma-glutamyltransferase or alkaline phosphatase or direct bilirubin.
- Subjects who have used one of the forbidden drugs or foods as following: o Excessive amounts (defined as daily intake of alcohol >40 g) of alcoholic beverages (eg, beer, wine, distilled spirits), or have a history of alcohol abuse, or are unwilling to comply with the restricted use of alcoholic beverages during the study.
- An investigational drug (new chemical entity) during the 90 days or 5 half-lives prior to day -7 (whichever is longer).
- Any medications, including over-the-counter medications or herbal preparations, used within 14 days prior to day -7 (except occasional paracetamol/acetaminophen or ibuprofen use and OC).
- Any contraindicated concomitant medication according to the OC labeling.
- Inducers or inhibitors of cytochrome P450 3A4 within 30 days prior to day -7.
- Subjects who have consumed grapefruit, grapefruit juice, Seville oranges and pomelo-containing products, within the 14 days (2 weeks) prior to day -7.
- Subjects with a positive urine drug test (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, tetrahydrocannabinol) or positive test for ethanol at screening or at day -7.
- Subjects who have donated or received any blood, plasma, or platelet transfusions in the 3 months prior to day -7, or who have made donations on more than 2 occasions within the 12 months preceding day -7, or who have planned donations during the study period or during the 3 months following the study.
- Subjects with a positive screening test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody at screening.
- Subjects who cannot participate or successfully complete the study, in the opinion of their general practitioner or the investigator, for the following reasons: o Subjects are under the legal age of consent or are mentally or legally incapacitated, or unable to give consent for any reason.
- Subjects who are in custody due to an administrative or a legal decision, or under tutelage, or being admitted to a sanitarium or social institution.
- Subjects unable to be contacted in case of emergency.
- Subjects who are employed by the Sponsor or the investigational site conducting the study
- Any other reason, at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Pharmacokinetics, Pharmacodynamics
- Being tested
- laquinimod, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laquinimodDrug
Also called TV5600
Oral laquinimod 0.6 mg capsules (with oral contraceptives tablets containing 30 μg ethinylestradiol and 150 μg levonorgestrel (Microgynon®)
PlaceboDrug
Placebo (with oral contraceptives tablets containing 30 μg ethinylestradiol and 150 μg levonorgestrel (Microgynon®)
| Study group | Role | What they receive |
|---|---|---|
| Laquinimod | Experimental | once daily oral doses of laquinimod (with combination oral contraceptives) Receives: Drug: laquinimod; Drug: Placebo |
| Placebo | Placebo comparator | Matching placebo (with combination oral contraceptives) Receives: Drug: laquinimod; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24 of EE and LNG plasma concentrations.
to assess the effect of once daily oral doses of laquinimod on the pharmacokinetics (PK) of ethinylestradiol (EE) and levonorgestrel (LNG)
Measured: 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 EE and LNG plasma concentrations.
to assess the effect of once daily oral doses of laquinimod on the pharmacokinetics (PK) of ethinylestradiol (EE) and levonorgestrel (LNG
Measured: 10 min prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose
Secondary outcomes (11)
Tmax of EE and LNG plasma concentrations
Measured: 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
Measured: 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
Measured: 10 min prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose
Ctrough of luteinizing hormone [LH], and follicle-stimulating hormone [FSH]
Measured: 10 min prior to dosing
Summary of Participants with Adverse Events
Measured: 25 Weeks
T1/2 of EE and LNG plasma concentrations
Measured: 10 min prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose
CL/F of EE and LNG plasma concentrations
Measured: 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
Measured: 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
Measured: 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 laquinimod plasma concentrations
Measured: 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
Measured: 10 min prior to dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085863
- Sponsor's protocol ID
- TV5600-PK-10017
- Other IDs
- 2013-005356-14
- Status last verified
- Nov 2021
- First submitted
- 11 Mar 2014
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02085863
- Acronym / sponsor ID
- TV5600-PK-10017
- Conditions
- Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laquinimod | Experimental | Drug: laquinimod, Drug: Placeboonce daily oral doses of laquinimod (with combination oral contraceptives) |
| Placebo | Placebo comparator | Drug: laquinimod, Drug: PlaceboMatching placebo (with combination oral contraceptives) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (28 listed)
- 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 -7.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laquinimodAlso: TV5600Oral laquinimod 0.6 mg capsules (with oral contraceptives tablets containing 30 μg ethinylestradiol and 150 μg levonorgestrel (Microgynon®) | Drug | Laquinimod, Placebo |
| PlaceboPlacebo (with oral contraceptives tablets containing 30 μg ethinylestradiol and 150 μg levonorgestrel (Microgynon®) | Drug | Laquinimod, Placebo |
Primary outcome
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
11 secondary outcomes
Tmax 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
Cmax of laquinimod 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
AUC0-24 of progesterone
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
Ctrough of luteinizing hormone [LH], and follicle-stimulating hormone [FSH]
Time frame: 10 min prior to dosing
Summary of Participants with Adverse Events
Time frame: 25 Weeks
T1/2 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
CL/F 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
V/F 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
Tmax of laquinimod 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
AUC0-24 of laquinimod 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
Cmax of progesterone
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing laquinimod in people with Pharmacokinetics and Pharmacodynamics, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.