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

Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study ID
NCT01714193
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Oral contraceptive — DRUG
    One tablet (0.150 mg of levonorgestrel and 0.030 mg of ethinyl estradiol) taken orally (by mouth) on Day 1 and Day 9.
  • Canagliflozin (JNJ-28431754) — DRUG
    One 200 mg tablet taken orally (by mouth) on Days 4 through 9.

Study Details

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.

Key Dates

Start date
Feb 29, 2008
Status verified
Nov 2012
Primary completion
Mar 31, 2008
Completion
Mar 31, 2008

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Canagliflozin + 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 Measure

Plasma concentrations of ethinyl estradiol and levonorgestrel [ Time Frame: Up to Day 12 ]

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