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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
400 mg sotagliflozin
0.25 mg norgestimate/0.035 mg ethinyl estradiol
0.25 mg norgestimate/0.035 mg ethinyl estradiol + 400 mg sotagliflozin
Lexicon Investigational Site
Evansville, Indiana, United States
Lexicon Investigational Site
Dallas, Texas, United States
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
Number of treatment emergent adverse events
Time frame: Day 1 to Day 70
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