A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics and Safety of an Oral Contraceptive in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Oral contraceptive; Drug: Canagliflozin (JNJ-28431754)

• Registration Number: NCT01714193
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

The purpose of this study is to investigate whether there is a drug-drug interaction between multiple doses of canagliflozin (JNJ-28431754) and single doses of an oral contraceptive containing ethinyl estradiol and levonorgestrel. The safety and tolerability of canagliflozin will also be assessed in healthy volunteers.

Detailed Description

This study will be an open-label (all volunteers and study staff know the identity of the assigned treatment), single-center, fixed-sequence study (all volunteers receive the same medication on the same days), to determine how canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) affects the pharmacokinetics (ie, how the body affects the drug) of an oral contraceptive containing ethinyl estradiol and levonorgestrel. The study will consist of 3 phases; a screening phase, an open-label treatment phase, and an end-of-study (or follow-up) phase. Each volunteer will participate in the study for approximately 33 days.

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-25
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-16
• Last Update Posted: 2012-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Volunteer must have a body mass index (weight [kg]/height [m2]) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
• Volunteer must be a non-smoker (has not used tobacco or nicotine products in 6 months)

Exclusion Criteria

• History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
• History of, or presence of, disorders commonly accepted as contraindications to sex hormonal therapy and contraindications to therapy with combined oral contraceptives
• Volunteer has used, or is currently using, any hormonal contraceptive within 30 days of admission to the study center or has received Depo Provera (or other combined contraceptive injection or hormonal contraceptive implant) in the 6 months prior to screening
• Volunteer is breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Canagliflozin + oral contraceptive	Canagliflozin (JNJ-28431754)	Each volunteer will receive a single dose of an oral contraceptive containing ethinyl estradiol and levonorgestrel on Day 1, followed by canagliflozin (JNJ-28431754) once daily on Days 4 through 8. On Day 9 volunteers will receive a single dose of an oral contraceptive containing ethinyl estradiol and levonorgestrel in combination with a single dose of canagliflozin.
Canagliflozin + oral contraceptive	Oral contraceptive	Each volunteer will receive a single dose of an oral contraceptive containing ethinyl estradiol and levonorgestrel on Day 1, followed by canagliflozin (JNJ-28431754) once daily on Days 4 through 8. On Day 9 volunteers will receive a single dose of an oral contraceptive containing ethinyl estradiol and levonorgestrel in combination with a single dose of canagliflozin.

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of ethinyl estradiol and levonorgestrel	Up to Day 12	Comparison of plasma concentrations of ethinyl estradiol and levonorgestrel, before and after administration of multiple doses of canagliflozin (JNJ-28431754). This will be used to determine whether there is a pharmacokinetic interaction between multiple doses of canagliflozin and single doses of an oral contraceptive containing ethinyl estradiol and levonorgestrel.

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of canagliflozin (JNJ-28431754)	Days 8 and 9	Comparison of plasma concentrations of canagliflozin (JNJ-28431754) before and after administration of a single dose of an oral contraceptive containing ethinyl estradiol and levonorgestrel. This will be used to determine whether there is a pharmacokinetic interaction between multiple doses of canagliflozin and single doses of an oral contraceptive containing ethinyl estradiol and levonorgestrel.