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

Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Oral contraceptive (Drug); Canagliflozin (JNJ-28431754) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Clinical Details

Official title: An Open-label Drug-Drug Interaction Study in Healthy Female Subjects to Explore the Effects of Multiple Doses of JNJ-28431754 on the Pharmacokinetics and Safety of Single Doses of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Plasma concentrations of ethinyl estradiol and levonorgestrel

Secondary outcome: Plasma concentrations of canagliflozin (JNJ-28431754)

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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: February 2008
Last updated: November 16, 2012

Page last updated: August 23, 2015

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