Trial Outcomes & Findings for Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body (NCT NCT00957944)

NCT ID: NCT00957944

Last Updated: 2014-10-27

Results Overview

The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 40 participants
• Primary outcome timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
• Results posted on: 2014-10-27

Participant Flow

A total of 40 healthy, male subjects has been randomized in order to complete the trial with at least 30 subjects eligible for the Pharmacokinetic Set (PKS). Baseline characteristics refer to the PKS.

One subject that fulfilled predefined criteria for patch adhesiveness was excluded from the PKS.

Participant milestones

Measure	Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND) Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm\^2 manufactured at LTS West Caldwell, USA) in first intervention period and Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm\^2 manufactured at LTS Andernach, Germany) in second intervention period (after washout period of at least 5 days)	Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL) Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm\^2 manufactured at LTS Andernach, Germany) in first intervention period and Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm\^2 manufactured at LTS West Caldwell, USA) in second intervention period (after washout period of at least 5 days)
First Intervention- 24 Hours STARTED	20	20
First Intervention- 24 Hours COMPLETED	20	19
First Intervention- 24 Hours NOT COMPLETED	0	1
Washout Period of at Least 5 Days STARTED	20	19
Washout Period of at Least 5 Days COMPLETED	20	19
Washout Period of at Least 5 Days NOT COMPLETED	0	0
Second Intervention- 24 Hours STARTED	20	19
Second Intervention- 24 Hours Pharmacokinetic Set (PKS)	20	18
Second Intervention- 24 Hours COMPLETED	20	19
Second Intervention- 24 Hours NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND) Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm\^2 manufactured at LTS West Caldwell, USA) in first intervention period and Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm\^2 manufactured at LTS Andernach, Germany) in second intervention period (after washout period of at least 5 days)	Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL) Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm\^2 manufactured at LTS Andernach, Germany) in first intervention period and Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm\^2 manufactured at LTS West Caldwell, USA) in second intervention period (after washout period of at least 5 days)
First Intervention- 24 Hours Withdrawal by Subject	0	1

Baseline Characteristics

Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body

Baseline characteristics by cohort

Measure	Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND) n=20 Participants Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm\^2 manufactured at LTS West Caldwell, USA) in first intervention period and Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm\^2 manufactured at LTS Andernach, Germany) in second intervention period (after washout period of at least 5 days)	Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL) n=18 Participants Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm\^2 manufactured at LTS Andernach, Germany) in first intervention period and Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm\^2 manufactured at LTS West Caldwell, USA) in second intervention period (after washout period of at least 5 days)	Total n=38 Participants Total of all reporting groups
Age, Continuous	37.0 years STANDARD_DEVIATION 11.7 • n=5 Participants	32.8 years STANDARD_DEVIATION 7.2 • n=7 Participants	35.0 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index (BMI)	25.03 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.16 • n=5 Participants	25.87 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.77 • n=7 Participants	25.43 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.00 • n=5 Participants
Height	1.82 meter (m) STANDARD_DEVIATION 0.07 • n=5 Participants	1.82 meter (m) STANDARD_DEVIATION 0.08 • n=7 Participants	1.82 meter (m) STANDARD_DEVIATION 0.08 • n=5 Participants
Weight	83.18 kilogram (kg) STANDARD_DEVIATION 9.62 • n=5 Participants	85.33 kilogram (kg) STANDARD_DEVIATION 8.75 • n=7 Participants	84.20 kilogram (kg) STANDARD_DEVIATION 9.16 • n=5 Participants

PRIMARY outcome

Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Population: Pharmacokinetic Set (PKS)

The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration.

Outcome measures

Measure	Treatment A (Test: PR 2.1.1 WCL) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
AUC(0-tz) of Unconjugated Rotigotine	4.3899 (ng/ mL)*h Standard Deviation 1.7959	4.4255 (ng/ mL)*h Standard Deviation 2.3969

PRIMARY outcome

Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Population: Pharmacokinetic Set (PKS)

The Cmax is the maximum plasma concentration.

Outcome measures

Measure	Treatment A (Test: PR 2.1.1 WCL) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
Cmax of Unconjugated Rotigotine	0.21103 ng/ mL Standard Deviation 0.08827	0.20386 ng/ mL Standard Deviation 0.10194

PRIMARY outcome

Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Population: Pharmacokinetic Set (PKS)

The AUC(0-∞) is the area under the plasma concentration- time curve from zero up to infinity

Outcome measures

Measure	Treatment A (Test: PR 2.1.1 WCL) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
AUC(0-∞) of Unconjugated Rotigotine	4.51237 (ng/ mL)*h Standard Deviation 1.80709	4.55159 (ng/ mL)*h Standard Deviation 2.42524

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Population: Pharmacokinetic Set (PKS)

The AUC(0-tz) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by apparent dose (mg).

Outcome measures

Measure	Treatment A (Test: PR 2.1.1 WCL) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine	2.23980 (ng/ mL)*(h/ mg) Standard Deviation 0.71015	2.23035 (ng/ mL)*(h/ mg) Standard Deviation 0.77992

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Population: Pharmacokinetic Set (PKS)

The AUC(0-tz) norm (BW) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration normalized by body weight (kg).

Outcome measures

Measure	Treatment A (Test: PR 2.1.1 WCL) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
AUC(0-tz) Norm (BW) of Unconjugated Rotigotine	364.930 (ng/ mL)*h*kg Standard Deviation 140.747	367.452 (ng/ mL)*h*kg Standard Deviation 189.279

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Population: Pharmacokinetic Set (PKS)

The AUC(0-∞) norm (apparent dose) is the area under the plasma concentration- time curve from zero up to infinity normalized by apparent dose (mg).

Outcome measures

Measure	Treatment A (Test: PR 2.1.1 WCL) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
AUC(0-∞) Norm (Apparent Dose)	2.30523 (ng/ mL)*(h/ mg) Standard Deviation 0.71105	2.29747 (ng/ mL)*(h/ mg) Standard Deviation 0.78191

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Population: Pharmacokinetic Set (PKS)

The AUC(0-∞) norm (BW) is the area under the plasma concentration- time curve from zero up to infinity normalized by body weight (kg).

Outcome measures

Measure	Treatment A (Test: PR 2.1.1 WCL) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
AUC(0-∞) Norm (BW)	375.224 (ng/ mL)*h*kg Standard Deviation 141.465	378.003 (ng/ mL)*h*kg Standard Deviation 191.344

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Population: Pharmacokinetic Set (PKS)

The Cmax,norm (apparent dose) is the maximum plasma concentration normalized by apparent dose(mg).

Outcome measures

Measure	Treatment A (Test: PR 2.1.1 WCL) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
Cmax,Norm (Apparent Dose) of Unconjugated Rotigotine	0.108148 (ng/ mL)/ mg Standard Deviation 0.037618	0.103965 (ng/ mL)/ mg Standard Deviation 0.035474

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Population: Pharmacokinetic Set (PKS)

The Cmax,norm (BW) is the maximum plasma concentration normalized by body weight(kg).

Outcome measures

Measure	Treatment A (Test: PR 2.1.1 WCL) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
Cmax,Norm (BW) of Unconjugated Rotigotine	17.6070 (ng/ mL) * kg Standard Deviation 7.2645	16.9748 (ng/ mL) * kg Standard Deviation 8.1930

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Population: Pharmacokinetic Set (PKS)

The tmax is the time to reach a maximum plasma concentration after patch application.

Outcome measures

Measure	Treatment A (Test: PR 2.1.1 WCL) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
Tmax of Unconjugated Rotigotine	16.00 hour (h) Full Range 4.92 • Interval 8.0 to 25.0	16.00 hour (h) Full Range 5.12 • Interval 8.0 to 26.0

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Population: Pharmacokinetic Set (PKS)

The MRT is the mean residence time.

Outcome measures

Measure	Treatment A (Test: PR 2.1.1 WCL) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
MRT of Unconjugated Rotigotine	19.914 hour (h) Standard Deviation 1.620	19.980 hour (h) Standard Deviation 2.038

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Population: Pharmacokinetic Set (PKS)

The λz is the rate constant of elimination.

Outcome measures

Measure	Treatment A (Test: PR 2.1.1 WCL) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
λz of Unconjugated Rotigotine	0.129745 1/ hour (1/h) Standard Deviation 0.026292	0.125217 1/ hour (1/h) Standard Deviation 0.027732

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Population: Pharmacokinetic Set (PKS)

The t1/2 is the terminal half- life.

Outcome measures

Measure	Treatment A (Test: PR 2.1.1 WCL) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
t1/2 of Unconjugated Rotigotine	5.5408 hour (h) Standard Deviation 1.0205	5.7878 hour (h) Standard Deviation 1.1985

SECONDARY outcome

Timeframe: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.

Population: Pharmacokinetic Set (PKS)

The CL/f is the apparent total body clearance.

Outcome measures

Measure	Treatment A (Test: PR 2.1.1 WCL) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
CL/f of Unconjugated Rotigotine	1185.98 L/h Standard Deviation 574.45	1227.56 L/h Standard Deviation 541.82

SECONDARY outcome

Timeframe: 48 hours

Population: Pharmacokinetic Set (PKS)

Apparent dose of unconjugated rotigotine in mg. The apparent dose of unconjugated rotigotine was determined from the patches removed on Day 2.

Outcome measures

Measure	Treatment A (Test: PR 2.1.1 WCL) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=38 Participants Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
Apparent Dose	1.932 mg Standard Deviation 0.398	1.927 mg Standard Deviation 0.489

Adverse Events

Treatment A (Test: PR 2.1.1 WCL)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Treatment B (Reference: PR 2.1.1 AND)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment A (Test: PR 2.1.1 WCL) n=39 participants at risk Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours	Treatment B (Reference: PR 2.1.1 AND) n=40 participants at risk Rotigotine transdermal patch (4.5 mg/10 cm\^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
Gastrointestinal disorders Nausea	0.00% 0/39 • Adverse Events (AEs) were collected up to 18 days from Day -1 (day before first dosing) to the Safety Follow- Up Visit. Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who are randomized and received at least one dose of study medication.	2.5% 1/40 • Number of events 1 • Adverse Events (AEs) were collected up to 18 days from Day -1 (day before first dosing) to the Safety Follow- Up Visit. Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who are randomized and received at least one dose of study medication.
General disorders Application Site Pruritus	10.3% 4/39 • Number of events 4 • Adverse Events (AEs) were collected up to 18 days from Day -1 (day before first dosing) to the Safety Follow- Up Visit. Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who are randomized and received at least one dose of study medication.	7.5% 3/40 • Number of events 3 • Adverse Events (AEs) were collected up to 18 days from Day -1 (day before first dosing) to the Safety Follow- Up Visit. Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who are randomized and received at least one dose of study medication.
General disorders Fatigue	2.6% 1/39 • Number of events 1 • Adverse Events (AEs) were collected up to 18 days from Day -1 (day before first dosing) to the Safety Follow- Up Visit. Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who are randomized and received at least one dose of study medication.	0.00% 0/40 • Adverse Events (AEs) were collected up to 18 days from Day -1 (day before first dosing) to the Safety Follow- Up Visit. Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who are randomized and received at least one dose of study medication.
Vascular disorders Hot Flush	2.6% 1/39 • Number of events 1 • Adverse Events (AEs) were collected up to 18 days from Day -1 (day before first dosing) to the Safety Follow- Up Visit. Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who are randomized and received at least one dose of study medication.	0.00% 0/40 • Adverse Events (AEs) were collected up to 18 days from Day -1 (day before first dosing) to the Safety Follow- Up Visit. Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who are randomized and received at least one dose of study medication.
Nervous system disorders Headache	0.00% 0/39 • Adverse Events (AEs) were collected up to 18 days from Day -1 (day before first dosing) to the Safety Follow- Up Visit. Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who are randomized and received at least one dose of study medication.	2.5% 1/40 • Number of events 1 • Adverse Events (AEs) were collected up to 18 days from Day -1 (day before first dosing) to the Safety Follow- Up Visit. Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who are randomized and received at least one dose of study medication.
Psychiatric disorders Sleep Disorder	0.00% 0/39 • Adverse Events (AEs) were collected up to 18 days from Day -1 (day before first dosing) to the Safety Follow- Up Visit. Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who are randomized and received at least one dose of study medication.	2.5% 1/40 • Number of events 1 • Adverse Events (AEs) were collected up to 18 days from Day -1 (day before first dosing) to the Safety Follow- Up Visit. Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who are randomized and received at least one dose of study medication.

Additional Information

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