Study of the Effect of ITCA 650 on the PK/PD of Oral Contraceptive in Healthy Female Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

February 29, 2016

Study Completion Date

February 29, 2016

Conditions
Healthy Adult Premenopausal Female Volunteers
Interventions
DRUG

ITCA 650 20/60 mcg/day, ITCA placebo

ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day and Levora® for 28 days, followed by ITCA osmotic mini pump delivering placebo and Levora® for 28 days

DRUG

ITCA placebo, ITCA 650 20/60 mcg/day

ITCA osmotic mini pump delivering placebo and Levora® for 28 days, followed by Levora® and ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day and Levora® for 28 days

Trial Locations (2)

32806

Compass Research, Orlando

33143

QPS/Miami Research Associates, Miami

Sponsors
All Listed Sponsors
lead

Intarcia Therapeutics

INDUSTRY