HealthyPhase 1NCT02494609
Oral Contraceptive DDI Study
A Phase 1 study testing sotagliflozin, oral contraceptive and oral contraceptive + sotagliflozin in people with Healthy, run by Lexicon Pharmaceuticals at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- sotagliflozin, oral contraceptive and oral contraceptive + sotagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to Nov 2015
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lexicon Investigational Site
Dallas, Texas, 75247
Lexicon Investigational Site
Evansville, Indiana, 47710
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- sotagliflozin, oral contraceptive, oral contraceptive + sotagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sotagliflozinDrug
400 mg sotagliflozin
oral contraceptiveDrug
0.25 mg norgestimate/0.035 mg ethinyl estradiol
oral contraceptive + sotagliflozinDrug
0.25 mg norgestimate/0.035 mg ethinyl estradiol + 400 mg sotagliflozin
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | once daily dosing for 7 days, followed by 7-day washout Receives: Drug: sotagliflozin |
| Treatment B | Experimental | once daily dosing for 28 days Receives: Drug: oral contraceptive |
| Treatment C | Experimental | once daily dosing for 14 days of oral contraceptive, followed by coadministration with sotagliflozin once daily for 7 days Receives: Drug: oral contraceptive + sotagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters
Measured: 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
Measured: Day 55 to Day 57, Day 62 to Day 64
Secondary outcomes (1)
Number of treatment emergent adverse events
Measured: Day 1 to Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suman Wason, MD, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494609
- Sponsor's protocol ID
- LX4211.1-120-NRM
- Other IDs
- LX4211.120
- Status last verified
- Feb 2016
- First submitted
- 8 Jul 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02494609
- Acronym / sponsor ID
- LX4211.1-120-NRM
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (actual)
- First posted
- 10 Jul 2015 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: sotagliflozinonce daily dosing for 7 days, followed by 7-day washout |
| Treatment B | Experimental | Drug: oral contraceptiveonce daily dosing for 28 days |
| Treatment C | Experimental | Drug: oral contraceptive + sotagliflozinonce daily dosing for 14 days of oral contraceptive, followed by coadministration with sotagliflozin once daily for 7 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| sotagliflozin400 mg sotagliflozin | Drug | Treatment A |
| oral contraceptive0.25 mg norgestimate/0.035 mg ethinyl estradiol | Drug | Treatment B |
| oral contraceptive + sotagliflozin0.25 mg norgestimate/0.035 mg ethinyl estradiol + 400 mg sotagliflozin | Drug | Treatment C |
Primary outcome
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
Plasma concentration of norgestimate/ethinyl estradiol to evaluate protocol specified PK parameters
Time frame: Day 55 to Day 57, Day 62 to Day 64
1 secondary outcome
Number of treatment emergent adverse events
Time frame: Day 1 to Day 70
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
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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.
Suman Wason, MD study director
Lexicon Pharmaceuticals, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sotagliflozin, oral contraceptive and oral contraceptive + sotagliflozin in people with Healthy, run by Lexicon Pharmaceuticals at 2 sites in United States.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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?
Results are not available in the source record.
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?
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). 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 2 Mar 2016; AzTrials last refreshed its copy on 29 Oct 2026.