Oral Contraceptive DDI Study

Sponsor

Lexicon Pharmaceuticals (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02494609

Collaborator

(none)

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: sotagliflozin Drug: oral contraceptive Drug: oral contraceptive + sotagliflozin	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A once daily dosing for 7 days, followed by 7-day washout	Drug: sotagliflozin 400 mg sotagliflozin
Experimental: Treatment B once daily dosing for 28 days	Drug: oral contraceptive 0.25 mg norgestimate/0.035 mg ethinyl estradiol
Experimental: Treatment C once daily dosing for 14 days of oral contraceptive, followed by coadministration with sotagliflozin once daily for 7 days	Drug: oral contraceptive + sotagliflozin 0.25 mg norgestimate/0.035 mg ethinyl estradiol + 400 mg sotagliflozin

Arm

Intervention/Treatment

Experimental: Treatment A

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

Drug: sotagliflozin

400 mg sotagliflozin

Experimental: Treatment B

once daily dosing for 28 days

Drug: oral contraceptive

0.25 mg norgestimate/0.035 mg ethinyl estradiol

Experimental: Treatment C

once daily dosing for 14 days of oral contraceptive, followed by coadministration with sotagliflozin once daily for 7 days

Drug: oral contraceptive + sotagliflozin

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Number of treatment emergent adverse events [Day 1 to Day 70]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lexicon Investigational Site	Evansville	Indiana	United States	47710
2	Lexicon Investigational Site	Dallas	Texas	United States	75247

Sponsors and Collaborators

Lexicon Pharmaceuticals

Investigators

Study Director: Suman Wason, MD, Lexicon Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lexicon Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT02494609

Other Study ID Numbers:

LX4211.1-120-NRM
LX4211.120

First Posted:

Jul 10, 2015

Last Update Posted:

Mar 2, 2016

Last Verified:

Feb 1, 2016

Additional relevant MeSH terms:

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

Contraceptive Agents

Contraceptives, Oral

Study Results

No Results Posted as of Mar 2, 2016