drugset / Trial / NCT02480881

A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)

NCT02480881

Phase 1 Completed 26 enrolled ViiV Healthcare GlaxoSmithKline · collab
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (DDI) study in healthy female subjects on oral contraceptives (OC). There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-663068 with OC will not affect the pharmacokinetics (PK) of either ethinyl estradiol (EE) or norethindrone (NE).

Timeline

Start
2015-07-07
Primary completion
2016-01-11
Completion
2016-01-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Fostemsavir Other / unclassified Oral
Subject Loestrin 1.5/30 Unknown Oral