Trial Outcomes & Findings for A Study in Healthy People to Measure the Amount of BI 655130 in the Blood After Injecting Different Doses Into Different Parts of the Body (NCT NCT03617835)

Last Updated: 2025-10-17

Results Overview

Maximum measured concentration of BI 655130 in plasma (Cmax), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

48 participants

Primary outcome timeframe

Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.

Results posted on

2025-10-17

Participant Flow

A single dose, mono-centric, open-label study in matched-group design, that is, subjects assigned to the 3 test treatment groups were matched on an individual level for gender and body weight to subjects assigned to the reference treatment group.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	R - Low Dose of BI 655130 Periumbilical Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.	T1 - Low Dose of BI 655130 Periumbilical (Left and Right) Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.	T2 - Low Dose of BI 655130 Thigh Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.	T3 - High Dose of BI 655130 Periumbilical (Left and Right) Single high dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 2 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.
Overall Study STARTED	12	12	12	12
Overall Study COMPLETED	12	12	12	12
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study in Healthy People to Measure the Amount of BI 655130 in the Blood After Injecting Different Doses Into Different Parts of the Body

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	R - Low Dose of BI 655130 Periumbilical n=12 Participants Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.	T1 - Low Dose of BI 655130 Periumbilical (Left and Right) n=12 Participants Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.	T2 - Low Dose of BI 655130 Thigh n=12 Participants Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.	T3 - High Dose of BI 655130 Periumbilical (Left and Right) n=12 Participants Single high dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 2 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.	Total n=48 Participants Total of all reporting groups
Age, Continuous	33.2 years STANDARD_DEVIATION 9.5 • n=5 Participants	37.1 years STANDARD_DEVIATION 5.7 • n=7 Participants	37.4 years STANDARD_DEVIATION 7.5 • n=5 Participants	35.2 years STANDARD_DEVIATION 9.2 • n=4 Participants	35.7 years STANDARD_DEVIATION 8.1 • n=21 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	40 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	47 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	46 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.

Population: Pharmacokinetic (PK) parameter set: all participants in the Treated set (all participants who received at least one dose of study drug) who provided at least one primary or secondary PK parameter that was not excluded because of important protocol deviations relevant to the statistical evaluation of PK endpoints or because of non-evaluability.

Area under the concentration-time curve of BI 655130 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.

Outcome measures

Outcome measures
Measure	R - Low Dose of BI 655130 Periumbilical n=12 Participants Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.	T1 - Low Dose of BI 655130 Periumbilical (Left and Right) n=12 Participants Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.	T2 - Low Dose of BI 655130 Thigh n=12 Participants Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)	1227.91 day * microgram / milliliter Standard Error NA The Standard Error is geometric standard error = 1.08.	1150.18 day * microgram / milliliter Standard Error NA The Standard Error is geometric standard error = 1.08.	1718.47 day * microgram / milliliter Standard Error NA The Standard Error is geometric standard error = 1.08.

PRIMARY outcome

Area under the concentration-time curve of BI 655130 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R. mL = milliliter, mg = milligram.

Outcome measures

Outcome measures
Measure	R - Low Dose of BI 655130 Periumbilical n=12 Participants Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.	T1 - Low Dose of BI 655130 Periumbilical (Left and Right) n=12 Participants Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.	T2 - Low Dose of BI 655130 Thigh Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz), Dose-Normalized	4.09 day * microgram * (1 / mL) * (1 / mg) Standard Error NA The Standard Error is geometric standard error = 1.08.	4.99 day * microgram * (1 / mL) * (1 / mg) Standard Error NA The Standard Error is geometric standard error = 1.08.	—

PRIMARY outcome

Maximum measured concentration of BI 655130 in plasma (Cmax). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.

Outcome measures

Outcome measures
Measure	R - Low Dose of BI 655130 Periumbilical n=12 Participants Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.	T1 - Low Dose of BI 655130 Periumbilical (Left and Right) n=12 Participants Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.	T2 - Low Dose of BI 655130 Thigh n=12 Participants Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.
Maximum Measured Concentration of BI 655130 in Plasma (Cmax)	24.56 microgram / milliliter Standard Error NA The Standard Error is geometric standard error = 1.08.	24.35 microgram / milliliter Standard Error NA The Standard Error is geometric standard error = 1.08.	38.36 microgram / milliliter Standard Error NA The Standard Error is geometric standard error = 1.08.

PRIMARY outcome

Outcome measures

Outcome measures
Measure	R - Low Dose of BI 655130 Periumbilical n=12 Participants Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.	T1 - Low Dose of BI 655130 Periumbilical (Left and Right) n=12 Participants Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.	T2 - Low Dose of BI 655130 Thigh Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.
Maximum Measured Concentration of BI 655130 in Plasma (Cmax), Dose-Normalized	0.08 (microgram / milliliter) / milligram Standard Error NA The Standard Error is geometric standard error = 1.08.	0.11 (microgram / milliliter) / milligram Standard Error NA The Standard Error is geometric standard error = 1.08.	—

SECONDARY outcome

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.

Outcome measures

Outcome measures
Measure	R - Low Dose of BI 655130 Periumbilical n=12 Participants Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.	T1 - Low Dose of BI 655130 Periumbilical (Left and Right) n=12 Participants Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.	T2 - Low Dose of BI 655130 Thigh n=12 Participants Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)	1243.29 day * microgram / milliliter Standard Error NA The Standard Error is geometric standard error = 1.08.	1163.47 day * microgram / milliliter Standard Error NA The Standard Error is geometric standard error = 1.08.	1737.28 day * microgram / milliliter Standard Error NA The Standard Error is geometric standard error = 1.08.

SECONDARY outcome

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R. mL = milliliter, mg = milligram.

Outcome measures

Outcome measures
Measure	R - Low Dose of BI 655130 Periumbilical n=12 Participants Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.	T1 - Low Dose of BI 655130 Periumbilical (Left and Right) n=12 Participants Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.	T2 - Low Dose of BI 655130 Thigh Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞), Dose-Normalized	4.14 day * microgram * (1 / mL) * (1 / mg) Standard Error NA The Standard Error is geometric standard error = 1.08.	5.03 day * microgram * (1 / mL) * (1 / mg) Standard Error NA The Standard Error is geometric standard error = 1.08.	—

Adverse Events

R - Low Dose of BI 655130 Periumbilical

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

T1 - Low Dose of BI 655130 Periumbilical (Left and Right)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

T3 - High Dose of BI 655130 Periumbilical (Left and Right)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

T2 - Low Dose of BI 655130 Thigh

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	R - Low Dose of BI 655130 Periumbilical n=12 participants at risk Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.	T1 - Low Dose of BI 655130 Periumbilical (Left and Right) n=12 participants at risk Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.	T3 - High Dose of BI 655130 Periumbilical (Left and Right) n=12 participants at risk Single high dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 2 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.	T2 - Low Dose of BI 655130 Thigh n=12 participants at risk Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.
Nervous system disorders Headache	75.0% 9/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	33.3% 4/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	41.7% 5/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	25.0% 3/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Nervous system disorders Paraesthesia	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
General disorders Injection site erythema	25.0% 3/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	25.0% 3/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	50.0% 6/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	16.7% 2/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
General disorders Fatigue	16.7% 2/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
General disorders Injection site haematoma	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
General disorders Injection site reaction	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
General disorders Injection site swelling	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Acne	50.0% 6/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	41.7% 5/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	16.7% 2/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	41.7% 5/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal discomfort	25.0% 3/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	16.7% 2/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	16.7% 2/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Gastrointestinal disorders Aphthous ulcer	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	25.0% 3/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	16.7% 2/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	16.7% 2/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Infections and infestations Pharyngitis	16.7% 2/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Infections and infestations Cystitis	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Infections and infestations Herpes zoster	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Infections and infestations Rhinitis	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Infections and infestations Sinusitis	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Throat irritation	25.0% 3/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	16.7% 2/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Skin wound	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Investigations Transaminases increased	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Psychiatric disorders Major depression	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Renal and urinary disorders Dysuria	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.
Vascular disorders Hot flush	8.3% 1/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.	0.00% 0/12 • On-treatment-period, i.e. time of administration of study drug + 1 day + residual effect period of 112 days (16 weeks), up to 113 days. All participants who received at least one dose of study drug.