Pharmacokinetic Study Of AGILE AG200-15 After Weekly Application Under Various Conditions in Healthy Female Volunteers

NCT01375946 | Completed Phase 1 Results

• 1 other identifier: ATI-CL16
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A study to evaluate pharmacokinetic profile, wearability and safety of AG200-15, transdermal delivery of levonorgestrel (LNG) and ethinyl estradiol (EE), under normal conditions and external conditions of heat, humidity, cold water and exercise.

Conditions

Healthy

Keywords

Pharmacokinetic Profile (PK) and Safety; PK analysis of EE and LNG

Outcome Measures

Primary Outcomes (4)

• Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG)

  AUC(0-168) profile of LNG for each external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 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

• AUC(0-168) Profile of Ethinyl Estradiol (EE)

  AUC(0-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 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 of LNG

  Css (48-168) profile of LNG for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 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

• Css (48-168) Profile of EE

  Css (48-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 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

Secondary Outcomes (1)

• Patch Adhesion

  6 weeks

Study Arms (1)

AG200-15 location

EXPERIMENTAL

The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).

Drug: AG200-15

Interventions

AG200-15 DRUG

There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks.

Also known as: transdermal contraceptive delivery system, patch

AG200-15 location

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
• Body mass index (BMI)of ≥18 and less than or equal to 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

You may not qualify if:

• Known or suspected pregnancy
• Breast-feeding or within 1 month after stopping breast-feeding
• Smokers
• Any disease that may worsen with hormonal treatment
• Hypersensitivity to transdermal preparations or sensitivity to surgical/medical tape

Sponsors & Collaborators

• Agile Therapeutics: lead

Study Sites (1)

Clinical Pharmacology of Miami, Inc.

Miami, Florida, 33014, United States

Location

MeSH Terms

Interventions

Transdermal Patch

Intervention Hierarchy (Ancestors)

Equipment and Supplies

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, MPH

  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: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 20, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 31, 2018
• Results First Posted: December 21, 2017

Record last verified: 2018-07

Locations

US (1)