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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AG200-15

• Registration Number: NCT01422135
• Lead Sponsor: Agile Therapeutics

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2011-02
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2011-08-19
• Study First Submitted QC: 2011-08-22
• Study First Posted: 2011-08-23
• Results First Submitted: 2017-07-24
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-03
• Last Update Submitted: 2018-07-03
• Results First Posted: 2018-12-31
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Abdomen, Buttock, Upper Torso	AG200-15	Patch was placed on abdomen, buttock then the upper torso excluding breast. Intervention: AG200-15 patch
Buttock, Abdomen, Upper Torso	AG200-15	Patch was placed on the buttock, abdomen, then the upper torso excluding breast. Intervention: AG200-15 patch
Upper Torso, Abdomen, Buttock	AG200-15	Patch was placed on the upper torso excluding breast, abdomen then buttock. Intervention: AG200-15 patch
Buttock, Upper Torso, Abdomen,	AG200-15	Patch was placed on the buttock, upper torso excluding breast then the abdomen Intervention: AG200-15 patch
Upper Torso, Buttock, Abdomen	AG200-15	Patch was place on the upper torso excluding breast, buttock, then abdomen. Intervention: AG200-15 patch
Abdomen, Upper Torso, Buttock	AG200-15	Patch was placed on abdomen, upper torso excluding breast then the buttock. Intervention: AG200-15 patch

Primary Outcome Measures

Name	Time	Method
Steady-State Concentration (Css) (48-168) Profile for EE	6 weeks	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.
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for EE	6 weeks	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.
Steady-State Concentration (Css) (48-168) Profile for LNG	6 weeks	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.
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for LNG	6 weeks	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.