Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Single Escalating Doses of BI 1034020 Administered Intravenously or Subcutaneously to Male Healthy Volunteers

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01958060
• Collaborator: (none)
• Enrollment: 35
• Locations: 2
• Arms: 2
• Duration (Months): 6
• Patients Per Site: 17.5
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

Investigation of safety and tolerability of BI 1034020 in healthy male volunteers following intravenous (IV) infusion of subcutaneous (SC) injection of single doses and exploration of the pharmacokinetics and pharmacodynamics of BI 1034020 after single dosing and determination of the bioavailability of subcutaneous injections of BI 1034020

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 1034020; Drug: Placebo to BI 1034020	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Intravenous and Subcutaneous Doses of BI 1034020 in Healthy Male Volunteers (Partially Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 1034020 intravenous part single rising doses	Drug: BI 1034020; intravenous part; Drug: Placebo to BI 1034020; intravenous part
Experimental: BI 1034020 subcutaneous part single rising doses	Drug: BI 1034020; intravenous part; Drug: Placebo to BI 1034020; intravenous part

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects With Drug Related Adverse Events [from the first drug administration to end of trial, up to 50 days]

   Percentage of subjects with investigator defined drug-related adverse events

Secondary Outcome Measures

1. Cmax [2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.]

   Maximum measured concentration of BI 1034020 in plasma (Cmax).

2. AUC0-inf [2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.]

   Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). AUC0-inf could be assessed only in 50 mg iv dose group as terminal phase was below lower limit of quantification (BLQ) for other dose groups. Therefore dose proportionality for AUC0-inf could not be performed in this trial.

3. AUC0-tz [2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.]

   Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose (AUC0-tz ).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

1. Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests

2. Age within the range of 18 to 40 years

3. Body mass index within the range of 18.5 and 29.9 kg/m2

4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Exclusion criteria:

1. Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement

2. Any evidence of a clinically relevant concomitant disease.

3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.

4. Surgery of the gastrointestinal tract (except appendectomy).

5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.

6. History of relevant orthostatic hypotension, fainting spells or blackouts.

7. Chronic or relevant acute infections.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1312.1.1 Boehringer Ingelheim Investigational Site	Biberach		Germany
2	1312.1.2 Boehringer Ingelheim Investigational Site	Ingelheim		Germany

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT01958060
• Other Study ID Numbers: 1312.1; 2011-004615-23
• First Posted: Oct 8, 2013
• Last Update Posted: Jul 30, 2015
• Last Verified: Jul 1, 2015

Study Results

Participant Flow

Recruitment Details	This trial was initiated at two centres. As one of the trial centres did not enrol any subjects by the time of premature termination of the trial; the trial was conducted only at one centre.
Pre-assignment Detail	Partially randomised, placebo-controlled within dose groups, single-blind, single rising dose, multiple centres (dose escalation intravenous [iv] bridging to subcutaneous [sc] in parallel). 35 subjects were enrolled and 32 subjects were treated.

Arm/Group Title	Placebo	BI 1034020 (5 mg/25 mL - iv)	BI 1034020 (10 mg/25 mL - iv)	BI 1034020 (20 mg/25 mL - iv)	BI 1034020 (50 mg/25 mL - iv)	BI 1034020 (100 mg/25 mL - iv)
Arm/Group Description	Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
Period Title: Overall Study
STARTED	10	6	6	5	7	1
COMPLETED	8	6	6	5	6	1
NOT COMPLETED	2	0	0	0	1	0

Baseline Characteristics

Arm/Group Title	Placebo	BI 1034020 (5 mg/25 mL - iv)	BI 1034020 (10 mg/25 mL - iv)	BI 1034020 (20 mg/25 mL - iv)	BI 1034020 (50 mg/25 mL - iv)	BI 1034020 (100 mg/25 mL - iv)	Total
Arm/Group Description	Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Total of all reporting groups
Overall Participants	8	6	6	5	6	1	32
Age (Year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Year]	26.5 (4.3)	32.5 (3.9)	33.2 (3.4)	31.4 (4.0)	34.3 (4.0)	23.0 (NA)	31.0 (4.9)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	8 100%	6 100%	6 100%	5 100%	6 100%	1 100%	32 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Drug Related Adverse Events
Description	Percentage of subjects with investigator defined drug-related adverse events
Time Frame	from the first drug administration to end of trial, up to 50 days

Outcome Measure Data

Analysis Population Description

Treated Set (TS)

Arm/Group Title	Placebo	BI 1034020 (5 mg/25 mL - iv)	BI 1034020 (10 mg/25 mL - iv)	BI 1034020 (20 mg/25 mL - iv)	BI 1034020 (50 mg/25 mL - iv)	BI 1034020 (100 mg/25 mL - iv)
Arm/Group Description	Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
Measure Participants	8	6	6	5	6	1
Number [percentage of participants]	37.5 468.8%	33.3 555%	33.3 555%	0.0 0%	50.0 833.3%	100.0 10000%

2. Secondary Outcome

Title	Cmax
Description	Maximum measured concentration of BI 1034020 in plasma (Cmax).
Time Frame	2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Set (PKS): This subject set included all subjects in the treated set who provide at least 1 observation for at least 1 secondary Pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK.

Arm/Group Title	BI 1034020 (5 mg/25 mL - iv)	BI 1034020 (10 mg/25 mL - iv)	BI 1034020 (20 mg/25 mL - iv)	BI 1034020 (50 mg/25 mL - iv)
Arm/Group Description	Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
Measure Participants	6	6	5	5
Geometric Mean (Geometric Coefficient of Variation) [μg/mL]	1.50 (8.69)	3.30 (17.6)	6.90 (15.7)	17.2 (11.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, BI 1034020 (5 mg/25 mL - iv), BI 1034020 (10 mg/25 mL - iv), BI 1034020 (20 mg/25 mL - iv)
	Comments	This was non confirmatory testing (Single dose). Dose proportionality of BI 1034020 following iv administration of single rising doses of 5 mg, 10 mg, 20 mg and 50 mg for Cmax was analysed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.0604
	Confidence Interval	(2-Sided) 95%; 0.9901 to 1.1308
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0337
	Estimation Comments	Dose proportionality was explored using linear regression model (ANOVA).The perfect dose proportionality would correspond to a slope β of 1.PK endpoints on the log-transformed scale.Standard error (SE) of the mean is actually the SE of the slope.

3. Secondary Outcome

Title	AUC0-inf
Description	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). AUC0-inf could be assessed only in 50 mg iv dose group as terminal phase was below lower limit of quantification (BLQ) for other dose groups. Therefore dose proportionality for AUC0-inf could not be performed in this trial.
Time Frame	2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.

Outcome Measure Data

Analysis Population Description

Pharmacokinetic set (PKS):

Arm/Group Title	BI 1034020 (50 mg/25 mL - iv)
Arm/Group Description	Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
Measure Participants	4
Geometric Mean (Geometric Coefficient of Variation) [μg*h/mL]	314 (7.66)

4. Secondary Outcome

Title	AUC0-tz
Description	Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose (AUC0-tz ).
Time Frame	2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.

Outcome Measure Data

Analysis Population Description

Pharmacokinetic set (PKS)

Arm/Group Title	BI 1034020 (5 mg/25 mL - iv)	BI 1034020 (10 mg/25 mL - iv)	BI 1034020 (20 mg/25 mL - iv)	BI 1034020 (50 mg/25 mL - iv)
Arm/Group Description	Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
Measure Participants	6	6	5	5
Geometric Mean (Geometric Coefficient of Variation) [μg*h/mL]	7.30 (9.60)	20.1 (28.5)	83.7 (94.4)	242 (15.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, BI 1034020 (5 mg/25 mL - iv), BI 1034020 (10 mg/25 mL - iv), BI 1034020 (20 mg/25 mL - iv)
	Comments	This was non confirmatory testing (Single dose). Dose proportionality of BI 1034020 following iv administration of single rising doses of 5 mg, 10 mg, 20 mg and 50 mg for AUClast was analysed.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	1.5629
	Confidence Interval	(2-Sided) 95%; 1.3426 to 1.7833
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.1056
	Estimation Comments	Dose proportionality was explored using the linear regression model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.Standard error of the mean is actually the standard error of the slope.

Adverse Events

Time Frame	from the first drug administration to end of trial, up to 50 days
Arm/Group Title	Placebo		BI 1034020 (5 mg/25 mL - iv)		BI 1034020 (10 mg/25 mL - iv)		BI 1034020 (20 mg/25 mL - iv)		BI 1034020 (50 mg/25 mL - iv)		BI 1034020 (100 mg/25 mL - iv)
Arm/Group Description	Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.		Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.		Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.		Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.		Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.		Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
All Cause Mortality
	Placebo		BI 1034020 (5 mg/25 mL - iv)		BI 1034020 (10 mg/25 mL - iv)		BI 1034020 (20 mg/25 mL - iv)		BI 1034020 (50 mg/25 mL - iv)		BI 1034020 (100 mg/25 mL - iv)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		BI 1034020 (5 mg/25 mL - iv)		BI 1034020 (10 mg/25 mL - iv)		BI 1034020 (20 mg/25 mL - iv)		BI 1034020 (50 mg/25 mL - iv)		BI 1034020 (100 mg/25 mL - iv)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/1 (100%)
Immune system disorders
Anaphylactoid reaction	0/8 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/1 (100%)
Other (Not Including Serious) Adverse Events
	Placebo		BI 1034020 (5 mg/25 mL - iv)		BI 1034020 (10 mg/25 mL - iv)		BI 1034020 (20 mg/25 mL - iv)		BI 1034020 (50 mg/25 mL - iv)		BI 1034020 (100 mg/25 mL - iv)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/8 (75%)		3/6 (50%)		4/6 (66.7%)		3/5 (60%)		5/6 (83.3%)		1/1 (100%)
Cardiac disorders
Palpitations	1/8 (12.5%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Sinus tachycardia	0/8 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/1 (100%)
Eye disorders
Photopsia	0/8 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/1 (0%)
Gastrointestinal disorders
Abdominal distension	0/8 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Abdominal pain	1/8 (12.5%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Diarrhoea	1/8 (12.5%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Faeces discoloured	1/8 (12.5%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Inguinal hernia	0/8 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Nausea	1/8 (12.5%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Vomiting	1/8 (12.5%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
General disorders
Chest discomfort	0/8 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Fatigue	0/8 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/1 (0%)
Injection site haematoma	0/8 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/1 (100%)
Immune system disorders
Hypersensitivity	0/8 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/1 (0%)
Seasonal allergy	0/8 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		2/6 (33.3%)		0/1 (0%)
Infections and infestations
Herpes zoster	0/8 (0%)		1/6 (16.7%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Nasopharyngitis	1/8 (12.5%)		1/6 (16.7%)		2/6 (33.3%)		1/5 (20%)		1/6 (16.7%)		0/1 (0%)
Rhinitis	0/8 (0%)		1/6 (16.7%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/1 (0%)
Sinusitis	1/8 (12.5%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Injury, poisoning and procedural complications
Contusion	0/8 (0%)		0/6 (0%)		0/6 (0%)		2/5 (40%)		0/6 (0%)		0/1 (0%)
Laceration	1/8 (12.5%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Ligament sprain	0/8 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Road traffic accident	0/8 (0%)		0/6 (0%)		0/6 (0%)		1/5 (20%)		0/6 (0%)		0/1 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/8 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Joint swelling	0/8 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Nervous system disorders
Headache	3/8 (37.5%)		2/6 (33.3%)		1/6 (16.7%)		1/5 (20%)		4/6 (66.7%)		0/1 (0%)
Psychiatric disorders
Insomnia	1/8 (12.5%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/8 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		0/6 (0%)		1/1 (100%)
Nasal congestion	0/8 (0%)		0/6 (0%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Oropharyngeal pain	1/8 (12.5%)		1/6 (16.7%)		1/6 (16.7%)		0/5 (0%)		0/6 (0%)		0/1 (0%)
Skin and subcutaneous tissue disorders
Skin irritation	0/8 (0%)		0/6 (0%)		0/6 (0%)		0/5 (0%)		1/6 (16.7%)		0/1 (0%)

Limitations/Caveats

Due to a drug-related Serious Adverse event in the first subject of 100 mg BI 1034020 single iv dose group, the trial was prematurely terminated. No further iv dosing was performed and no planned sc dosing scheme was performed in this trial.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.