NCT01953809

A Pharmacokinetics, Pharmacodynamics, and Safety Study of an Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol When Co-administered With GSK1322322 in Healthy Adult Women

A Phase 1, Randomized, Single Blind Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of an Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol When Co-administered With GSK1322322 in Healthy Adult Women of Childbearing Age Who Are of Non-Childbearing Potential Due to Surgical Sterilization or IUD Placement (PDF112163)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to confirm that GSK1322322 has no negative impact on hormone levels and contraceptive efficacy when co-administered with a frequently prescribed oral contraceptive thereby to facilitate the use of GSK1322322 in women of child-bearing potential receiving oral contraceptive (OC) pre-infection. This study is designed to investigate steady-state plasma ethinyl estradiol (EE) and norethindrone (NE) pharmacokinetic (PK) following administration of Ortho-Novum (EE/NE) 1 tablet every 24 hours (q24h) fed with and without GSK1322322 1500 milligram (mg) q12h fed. Each subject will participate in the study for approximately 12 weeks: a 30 day screening period, 4-week run-in period, three 7 day treatment periods, and a 3-5 day follow-up period. The study is planned to enroll approximately 24 subjects (18 active/6 placebo).

Detailed description

Please note that Ortho-Novum is a registered trademark of Ortho Pharmaceutical Corporation.

Conditions

• Infections, Bacterial

Interventions

Type	Name	Description
DRUG	GSK1322322	Oral tablets with unit dose strength of 500mg and dose level of 1500mg (3 x 500mg) for twice a day administration for 7 days in treatment phase
DRUG	EE/NE	Oral contraceptive tablet containing 0.035mg EE and 1mg NE for once daily administration for 21 days in run-in phase and 21 days in treatment phase
DRUG	GSK1322322 Placebo	GSK1322322 matching placebo tablets for twice a day administration (3 tablets each time) for 7 days in treatment period.
DRUG	EE/NE Placebo	EE/NE matching placebo tablet for once daily administration for 7 days in run-in phase.

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-10-01
• Last updated: 2015-01-28