NCT02494609

Oral Contraceptive DDI Study

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	sotagliflozin	400 mg sotagliflozin
DRUG	oral contraceptive	0.25 mg norgestimate/0.035 mg ethinyl estradiol
DRUG	oral contraceptive + sotagliflozin	0.25 mg norgestimate/0.035 mg ethinyl estradiol + 400 mg sotagliflozin

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-11-01
• First posted: 2015-07-10
• Last updated: 2016-03-02

Locations

2 sites across 1 country: United States