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

Agile Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AG200-15

Study type: Interventional

Funder types: Industry

Identifiers

NCT01422135

ATI-CL15

Details and patient eligibility

About

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

Full 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).

Enrollment: 24 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Abdomen, Buttock, Upper Torso

Experimental group

Description:

Patch was placed on abdomen, buttock then the upper torso excluding breast. Intervention: AG200-15 patch

Treatment:

Drug: AG200-15

Abdomen, Upper Torso, Buttock

Experimental group

Description:

Patch was placed on abdomen, upper torso excluding breast then the buttock. Intervention: AG200-15 patch

Treatment:

Drug: AG200-15

Buttock, Abdomen, Upper Torso

Experimental group

Description:

Patch was placed on the buttock, abdomen, then the upper torso excluding breast. Intervention: AG200-15 patch

Treatment:

Drug: AG200-15

Buttock, Upper Torso, Abdomen,

Experimental group

Description:

Patch was placed on the buttock, upper torso excluding breast then the abdomen Intervention: AG200-15 patch

Treatment:

Drug: AG200-15

Upper Torso, Abdomen, Buttock

Experimental group

Description:

Patch was placed on the upper torso excluding breast, abdomen then buttock. Intervention: AG200-15 patch

Treatment:

Drug: AG200-15

Upper Torso, Buttock, Abdomen

Experimental group

Description:

Patch was place on the upper torso excluding breast, buttock, then abdomen. Intervention: AG200-15 patch

Treatment:

Drug: AG200-15