Oral Contraceptive DDI Study

Healthy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02494609
• Other study ID #: LX4211.1-120-NRM
• Secondary ID: LX4211.120
• Status: Active, not recruiting
• Phase: Phase 1
• First received: July 8, 2015
• Last updated: February 29, 2016
• Start date: July 2015

Study information

• Verified date: February 2016
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• sotagliflozin
400 mg sotagliflozin
• oral contraceptive
0.25 mg norgestimate/0.035 mg ethinyl estradiol
• oral contraceptive + sotagliflozin
0.25 mg norgestimate/0.035 mg ethinyl estradiol + 400 mg sotagliflozin

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	Dallas	Texas
United States	Lexicon Investigational Site	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of sotaglifozin to evaluate protocol specified PK parameters		Day 6 to Day 8, Day 55 to Day 57, Day 62 to Day 64	No
Primary	Plasma concentration of norgestimate/ethinyl estradiol to evaluate protocol specified PK parameters		Day 55 to Day 57, Day 62 to Day 64	No
Secondary	Number of treatment emergent adverse events		Day 1 to Day 70	Yes