NCT01422135 - Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females | Crick

Overview

This is a pharmacokinetics and safety study over 3 weekly applications.

Pharmacokinetic study to evaluate the safety and pharmacokinetic profile of AG200-15 following application at three different anatomical sites (abdomen, buttock and upper torso).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

24

Conditions

Healthy

Interventions

AG200-15DRUG

A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy women, ages 18-45 years * Body mass index 18 - 32, and weight ≥ 110 lbs. * Willing to use a non-hormonal method of contraception if of childbearing potential, Or have already undergone previous bilateral tubal ligation or hysterectomy * Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior to patch application until completion of each treatment period * Willing to give informed consent to participate in study * Hemoglobin within normal range. Exclusion Criteria: * Known or suspected pregnancy * A cervical cytology smear of Papanicolaou (Pap) class III or greater or a Bethesda System report of low grade squamous intraepithelial lesions (SIL) or greater * Smoking * Hypertension (blood pressure \>140 mm Hg systolic and/or \>90 mm Hg diastolic) * Diabetes Mellitus * History of headaches with focal neurological symptoms * Current or history of clinically significant depression in the last year * Acute or chronic hepatocellular disease with abnormal liver function * History of or existing venous and arterial thrombotic and thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease * Chronic use of any medication that might interfere with the efficacy of hormone contraceptives (including barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate, and HIV protease inhibitors), OR use of these medications within the past 3 months prior to screening visit

Locations (2)

Unnamed facility

Lincoln, Nebraska, United States

Unnamed facility

Neptune City, New Jersey, United States

Outcomes

Primary Outcomes

Steady-State Concentration (Css) (48-168) Profile for LNG

Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.

Time frame: 6 weeks

Steady-State Concentration (Css) (48-168) Profile for EE

Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.

Time frame: 6 weeks

Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for LNG

Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.

Time frame: 6 weeks

Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for EE

Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.

Time frame: 6 weeks