- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02494609
Oral Contraceptive DDI Study
February 29, 2016 updated by: Lexicon Pharmaceuticals
A Two-way Study to Evaluate the Potential Pharmacokinetic Interactions Between Sotagliflozin (LX4211) and Ortho-Cyclen®, an Oral Contraceptive Containing Norgestimate and Ethinyl Estradiol, in Healthy Premenopausal Women
A Two-way Study to Evaluate the Potential Pharmacokinetic Interactions Between Sotagliflozin (LX4211) and an Oral Contraceptive Containing Norgestimate and Ethinyl Estradiol, in Healthy Premenopausal Women.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Evansville, Indiana, United States, 47710
- Lexicon Investigational Site
-
-
Texas
-
Dallas, Texas, United States, 75247
- Lexicon Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Premenopausal females with a body mass index (BMI) between 18 and 32 kg/m2 (inclusive)
- Have not received any oral contraceptives during the Screening period or for at least 15 days prior to the first dose of Period 1
Exclusion Criteria:
- History of any contraindications to the combined oral contraceptive tablet including thrombosis and the history of any thromboembolic disease, recurrent jaundice, acute or chronic liver disease, hormonally-induced migraines, undiagnosed vaginal bleeding, significant hyperlipidemia, and mammary, endometrial, or hepatic carcinoma (known or suspected)
- Prior exposure to sotagliflozin (LX4211)
- History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality
- Concurrent conditions that could interfere with safety and/or tolerability measurements
- Women who are breastfeeding or are planning to become pregnant during the study
- Positive serum pregnancy test
- Have taken injectable contraceptives or hormonal intrauterine devices within 12 months prior to the first dose of Period 1 or topical controlled delivery contraceptives (patch) for 3 months prior to the first dose of Period 1
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment A
once daily dosing for 7 days, followed by 7-day washout
|
400 mg sotagliflozin
|
Experimental: Treatment B
once daily dosing for 28 days
|
0.25 mg norgestimate/0.035
mg ethinyl estradiol
|
Experimental: Treatment C
once daily dosing for 14 days of oral contraceptive, followed by coadministration with sotagliflozin once daily for 7 days
|
0.25 mg norgestimate/0.035
mg ethinyl estradiol + 400 mg sotagliflozin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters
Time Frame: Day 6 to Day 8, Day 55 to Day 57, Day 62 to Day 64
|
Day 6 to Day 8, Day 55 to Day 57, Day 62 to Day 64
|
Plasma concentration of norgestimate/ethinyl estradiol to evaluate protocol specified PK parameters
Time Frame: Day 55 to Day 57, Day 62 to Day 64
|
Day 55 to Day 57, Day 62 to Day 64
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of treatment emergent adverse events
Time Frame: Day 1 to Day 70
|
Day 1 to Day 70
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
July 8, 2015
First Submitted That Met QC Criteria
July 9, 2015
First Posted (Estimate)
July 10, 2015
Study Record Updates
Last Update Posted (Estimate)
March 2, 2016
Last Update Submitted That Met QC Criteria
February 29, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Reproductive Control Agents
- Contraceptive Agents, Female
- Sodium-Glucose Transporter 2 Inhibitors
- Contraceptive Agents
- Contraceptives, Oral
- (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Other Study ID Numbers
- LX4211.1-120-NRM
- LX4211.120 (Other Identifier: Lexicon Pharmaceuticals, Inc.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on sotagliflozin
-
University of NottinghamCompleted
-
University Medical Center GroningenJuvenile Diabetes Research Foundation; Lexicon PharmaceuticalsNot yet recruitingType 1 Diabetes Mellitus With Diabetic NephropathyNetherlands, United States, Canada, Denmark, Finland
-
Lexicon PharmaceuticalsCompletedHealthy | Renal ImpairmentUnited States
-
SanofiCompleted
-
Lexicon PharmaceuticalsSanofiCompletedType 2 Diabetes MellitusUnited States, Canada, Mexico
-
Lexicon PharmaceuticalsSanofiTerminatedCardiac Failure AggravatedUnited States, Canada, Netherlands
-
Juan BadimonRecruitingHeart Failure With Preserved Ejection FractionUnited States
-
Lexicon PharmaceuticalsSanofiCompletedType 1 Diabetes MellitusUnited States