Trial Outcomes & Findings for Pharmacokinetic Study Of AGILE AG200-15 After Weekly Application Under Various Conditions in Healthy Female Volunteers (NCT NCT01375946)

NCT ID: NCT01375946

Last Updated: 2018-07-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2018-07-31

Participant Flow

Participant milestones

Measure	AG200-15 Condition (NDC) The subject will wear AG200-15 for 7 days and be exposed to normal (N), dry sauna (D) then cold water (C)conditions	AG200-15 Condition (CNW) The subject will wear AG200-15 for 7 days and be exposed to cold water (C), normal (N) then whirlpool (W)conditions	AG200-15 Condition (WTN) The subject will wear AG200-15 for 7 days and be exposed to whirlpool (W), treadmill (T) then normal (N)conditions	AG200-15 Condition (NCD) The subject will wear AG200-15 for 7 days and be exposed to normal (N), cold water (C) then dry sauna (D)conditions	AG200-15 Condition (DNT) The subject will wear AG200-15 for 7 days and be exposed to dry sauna (D), normal (N) then treadmill (T)conditions	AG200-15 Condition (TWN) The subject will wear AG200-15 for 7 days and be exposed to treadmill (T), whirlpool (W) then normal (N) conditions
Overall Study STARTED	4	4	4	4	4	4
Overall Study COMPLETED	4	4	4	4	4	4
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	AG200-15 Condition n=24 Participants 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).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35.13 years STANDARD_DEVIATION 6.469 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Primary PK population

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.

Outcome measures

Measure	AG200-15 Condition n=24 Participants 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).
Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG) Normal	157 ng*hr/mL Standard Deviation 74
Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG) Dry Sauna	118 ng*hr/mL Standard Deviation 51
Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG) Cold water	153 ng*hr/mL Standard Deviation 76
Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG) Whirlpool	137 ng*hr/mL Standard Deviation 81
Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG) Treadmill	119 ng*hr/mL Standard Deviation 46

PRIMARY outcome

Timeframe: 6 weeks

Population: Primary PK population

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.

Outcome measures

Measure	AG200-15 Condition n=24 Participants 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).
AUC(0-168) Profile of Ethinyl Estradiol (EE) Normal	4.7 ng*hr/mL Standard Deviation 1.6
AUC(0-168) Profile of Ethinyl Estradiol (EE) Dry sauna	4.3 ng*hr/mL Standard Deviation 2.0
AUC(0-168) Profile of Ethinyl Estradiol (EE) Cold water	4.9 ng*hr/mL Standard Deviation 2.3
AUC(0-168) Profile of Ethinyl Estradiol (EE) Whirlpool	4.3 ng*hr/mL Standard Deviation 1.4
AUC(0-168) Profile of Ethinyl Estradiol (EE) Treadmill	3.9 ng*hr/mL Standard Deviation 1.1

PRIMARY outcome

Timeframe: 6 weeks

Population: Primary PK population

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.

Outcome measures

Measure	AG200-15 Condition n=24 Participants 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).
Steady-state Concentration (Css) (48-168) Profile of LNG Normal	1068 pg/mL Standard Deviation 494
Steady-state Concentration (Css) (48-168) Profile of LNG Dry Sauna	793 pg/mL Standard Deviation 317
Steady-state Concentration (Css) (48-168) Profile of LNG Cold water	1033 pg/mL Standard Deviation 518
Steady-state Concentration (Css) (48-168) Profile of LNG Whirlpool	918 pg/mL Standard Deviation 512
Steady-state Concentration (Css) (48-168) Profile of LNG Treadmill	814 pg/mL Standard Deviation 333

PRIMARY outcome

Timeframe: 6 weeks

Population: Primary PK population

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.

Outcome measures

Measure	AG200-15 Condition n=24 Participants 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).
Css (48-168) Profile of EE Normal	30 pg/mL Standard Deviation 12
Css (48-168) Profile of EE Dry Sauna	28 pg/mL Standard Deviation 13
Css (48-168) Profile of EE Cold water	29 pg/mL Standard Deviation 14
Css (48-168) Profile of EE Whirlpool	27 pg/mL Standard Deviation 9
Css (48-168) Profile of EE Treadmill	24 pg/mL Standard Deviation 8

SECONDARY outcome

Timeframe: 6 weeks

Population: Safety population

Patch adhesion scores by investigator evaluation by external condition; including dry sauna, whirlpool, treadmill exercise, normal, and cold water conditions; using the following scale:

0: >90% adhered (essentially no lift off of the skin)

1. >75% adhered but <90% (some edges showing lift)

2. >50% adhered but <75% (half of system lifts off)

3. <50% (> half of system lifts off, but undetached)

4. patch completely detached

Patches were assessed prior to patch removal.

Outcome measures

Measure	AG200-15 Condition n=24 Participants 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).
Patch Adhesion Normal	0.08 Score Standard Deviation 0.282
Patch Adhesion Dry Sauna	0.08 Score Standard Deviation 0.289
Patch Adhesion Cold water	0 Score Standard Deviation 0
Patch Adhesion Whirlpool	0 Score Standard Deviation 0
Patch Adhesion Treadmill	0.17 Score Standard Deviation 0.577

Adverse Events

AG200-15 Condition

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AG200-15 Condition n=24 participants at risk 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).
Gastrointestinal disorders Gastrointestinal disorders	50.0% 12/24 • Number of events 12 • 6 weeks
General disorders General disorders and administration site conditions	54.2% 13/24 • Number of events 13 • 6 weeks
Infections and infestations Infections and infestations	8.3% 2/24 • Number of events 2 • 6 weeks
Metabolism and nutrition disorders Metabolism and nutrition disorders	16.7% 4/24 • Number of events 4 • 6 weeks
Nervous system disorders Nervous system disorders	58.3% 14/24 • Number of events 14 • 6 weeks
Reproductive system and breast disorders Reproductive system and breast disorders	66.7% 16/24 • Number of events 16 • 6 weeks
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	8.3% 2/24 • Number of events 2 • 6 weeks

Additional Information

Joseph Chiodo III, Senior Medical Director

Agile Therapeutics

Phone: 609-683-1880

Email: jachiodo@agiletherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee Approval by Agile Therapeutics, Inc. of any publication, including oral presentations and abstracts, utilizing data or any information from the ATI-CL16 study is required prior to publication submission.
• Publication restrictions are in place

Restriction type: OTHER