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 30 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2008-02
Primary completion: 2008-03
Completion: 2008-03

Publications

Devineni D, Manitpisitkul P, Vaccaro N, Bernard A, Skee D, Mamidi RN, Tian H, Weiner S, Stieltjes H, Sha S, Rothenberg P. Effect of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on the pharmacokinetics of oral contraceptives, warfarin, and digoxin in healthy participants. Int J Clin Pharmacol Ther. 2015 Jan;53(1):41-53. doi: 10.5414/CP202157.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CANAGLIFLOZIN ANHYDROUS	Small molecule	200 mg	Oral
Subject	Levonorgestrel	Small molecule	0.15 mg	Oral
Subject	ethinyl estradiol	Small molecule	0.03 mg	Oral

Indications

No indication recorded.