Oral Contraceptive DDI Study

NCT02494609 | Unknown Phase 1

• 2 other identifiers: LX4211.1-120-NRMLX4211.120
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

• Plasma concentration of norgestimate/ethinyl estradiol to evaluate protocol specified PK parameters

  Day 55 to Day 57, Day 62 to Day 64

Secondary Outcomes (1)

• Number of treatment emergent adverse events

  Day 1 to Day 70

Study Arms (3)

Treatment A

EXPERIMENTAL

once daily dosing for 7 days, followed by 7-day washout

Drug: sotagliflozin

Treatment B

EXPERIMENTAL

once daily dosing for 28 days

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

Drug: oral contraceptive + sotagliflozin

Interventions

sotagliflozin DRUG

400 mg sotagliflozin

Treatment A

oral contraceptive DRUG

0.25 mg norgestimate/0.035 mg ethinyl estradiol

Treatment B

oral contraceptive + sotagliflozin DRUG

0.25 mg norgestimate/0.035 mg ethinyl estradiol + 400 mg sotagliflozin

Treatment C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lexicon Pharmaceuticals: lead

Study Sites (2)

Lexicon Investigational Site

Evansville, Indiana, 47710, United States

Location

Lexicon Investigational Site

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Contraceptives, Oral

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Suman Wason, MD

  Lexicon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 10, 2015
• Study Start: July 1, 2015
• Primary Completion: November 1, 2015
• Last Updated: March 2, 2016

Record last verified: 2016-02

Locations

US (2)