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

NCT01422135 | Completed Phase 1 Results

• 1 other identifier: ATI-CL15
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy

Keywords

PK and safety; Pharmacokinetic profile (PK) and safety

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  6 weeks

Study Arms (6)

Abdomen, Buttock, Upper Torso

EXPERIMENTAL

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

Drug: AG200-15

Abdomen, Upper Torso, Buttock

EXPERIMENTAL

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

Drug: AG200-15

Buttock, Abdomen, Upper Torso

EXPERIMENTAL

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

Drug: AG200-15

Buttock, Upper Torso, Abdomen,

EXPERIMENTAL

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

Drug: AG200-15

Upper Torso, Abdomen, Buttock

EXPERIMENTAL

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

Drug: AG200-15

Upper Torso, Buttock, Abdomen

EXPERIMENTAL

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

Drug: AG200-15

Interventions

AG200-15 DRUG

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.

Also known as: Transdermal contraceptive delivery system

Abdomen, Buttock, Upper Torso; Abdomen, Upper Torso, Buttock; Buttock, Abdomen, Upper Torso; Buttock, Upper Torso, Abdomen,; Upper Torso, Abdomen, Buttock; Upper Torso, Buttock, Abdomen

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Agile Therapeutics: lead

Study Sites (2)

Unknown Facility

Lincoln, Nebraska, 68502, United States

Location

Unknown Facility

Neptune City, New Jersey, 07753, United States

Location

Results Point of Contact

• Title: Joseph Chiodo III, Senior Medical Director
• Organization: Agile Therapeutics

jachiodo@agiletherapeutics.com

609-683-1880

Study Officials

• Elizabeth Garner, MD

  Agile Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 23, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: December 31, 2018
• Results First Posted: December 31, 2018

Record last verified: 2018-07

Locations

US (2)