Oral Contraceptive DDI Study

Conditions

• Healthy

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 45 Years

Healthy Volunteers

Accepted

Interventions

• sotagliflozin — DRUG
  400 mg sotagliflozin
• oral contraceptive — DRUG
  0.25 mg norgestimate/0.035 mg ethinyl estradiol
• oral contraceptive + sotagliflozin — DRUG
  0.25 mg norgestimate/0.035 mg ethinyl estradiol + 400 mg sotagliflozin

Study Details

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.

Key Dates

Start date

Jul 31, 2015

Status verified

Feb 2016

Primary completion

Nov 30, 2015

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment A
  once daily dosing for 7 days, followed by 7-day washout
• Experimental: Treatment B
  once daily dosing for 28 days
• Experimental: Treatment C
  once daily dosing for 14 days of oral contraceptive, followed by coadministration with sotagliflozin once daily for 7 days

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 ]

Locations (2)

Find similar trials in Evansville, IN

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