A Phase 1, randomized, double-blind, placebo-controlled, crossover study to assess the effect of ITCA 650 on the pharmacokinetics (PK) of once daily administration of Levora® (ethinyl estradiol 0.3 mg (EE) and levonorgestrel 0.15 mg (LNG) in healthy premenopausal female subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
28
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
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
QPS/Miami Research Associates
Miami, Florida, United States
Compass Research
Orlando, Florida, United States
Area under the plasma concentration-time curve at steady state (AUCss) for ethinyl estradiol and levonorgestrel
Time frame: from baseline to 13 weeks
Maximum steady state plasma concentration (Cmax,ss) for ethinyl estradiol and levonorgestrel
Time frame: from baseline to 13 weeks
Time to maximum steady state plasma concentration (tmax,ss) for ethinyl estradiol and levonorgestrel
Immunogenicity parameters: \- ADA (anti-exenatide antibodies) Safety parameters: \- Treatment-emergent AEs (TEAEs) including any events local to the placement site, clinical laboratory measurements, ECGs, vital signs and physical examinations.
Time frame: baseline to 13 weeks
Apparent plasma clearance at steady-state (CL/Fss) for ethinyl estradiol and levonorgestrel
Time frame: baseline to 13 weeks
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