This Study in Healthy Volunteers Determines the Amount of BI 730460 in the Blood When Taken as Tablet. It Looks at How Different Doses of BI 730460 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How Food Influences the Amount of BI 730460 in the Blood.

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03483077
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 7
• Actual Duration (Months): 5.4
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief Summary

The primary objective of the single-rising dose (SRD) part (trial part 1) is to investigate the safety and tolerability of BI 730460 in healthy subjects following oral administration of single rising doses. The secondary objective is the exploration of the pharmacokinetics (PK) including dose proportionality, and pharmacodynamics of BI 730460 after single dosing.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 730460; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Partially Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 730460 Administered as Tablets to Healthy Subjects, and a Randomised, Open-label, Single-dose, Two-way Cross-over Bioavailability Comparison of BI 730460 as Tablet With and Without Food
• Actual Study Start Date: Oct 9, 2018
• Actual Primary Completion Date: Mar 21, 2019
• Actual Study Completion Date: Mar 21, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo matching BI 730460 Placebo tablet(s) matching BI 730460 tablet(s) administered orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	Drug: Placebo; tablets
Experimental: 2 milligram (mg) - BI 730460 A single dose of 2 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	Drug: BI 730460; tablets
Experimental: 8 mg - BI 730460 A single dose of 8 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	Drug: BI 730460; tablets
Experimental: 25 mg - BI 730460 A single dose of 25 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	Drug: BI 730460; tablets
Experimental: 50 mg - BI 730460 A single dose of 50 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	Drug: BI 730460; tablets
Experimental: 100 mg - BI 730460 A single dose of 100 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	Drug: BI 730460; tablets
Experimental: 200 mg - BI 730460 A single dose of 200 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	Drug: BI 730460; tablets

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Drug-related Adverse Events [From drug administration until end of trial, up to 13 days.]

   Percentages are calculated using total number of participants per treatment as the denominator. MedDRA version used for reporting: 22.0.

Secondary Outcome Measures

1. Area Under the Concentration-time Curve of BI 730460 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) [Within 3 hours (h) prior to drug administration followed by 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 34.0, 48.0, 72.0, 96.0, 168.0 hours post drug administration.]

   Area under the concentration-time curve of BI 730460 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).

2. Maximum Measured Concentration of BI 730460 in Plasma [Within 3 hours (h) prior to drug administration followed by 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 34.0, 48.0, 72.0, 96.0, 168.0 hours post drug administration.]

   Maximum measured concentration of BI 730460 in plasma (Cmax).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

• Healthy male subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests

• Age of 18 to 45 years (incl.)

• Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)

• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria:

• Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator

• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)

• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

• Any evidence of a concomitant disease judged as clinically relevant by the investigator

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

• Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)

• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

• History of relevant orthostatic hypotension, fainting spells, or blackouts

• Chronic or relevant acute infections

• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)

• Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)

• Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug

• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)

• Inability to refrain from smoking on specified trial days

• Alcohol abuse (consumption of more than 30 g per day for males)

• Drug abuse or positive drug screening

• Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial

• Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial

• Inability to comply with dietary regimen of trial site

• A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males) or any other relevant Electrocardiogram (ECG) finding at screening

• A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)

• Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study

In addition, the following trial-specific exclusion criteria apply:

• Male subjects with women of childbearing potential (WOCBP) partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Humanpharmakologisches Zentrum Biberach	Biberach		Germany	88397

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jan 24, 2019
• Statistical Analysis Plan - May 6, 2019

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03483077
• Other Study ID Numbers: 1416-0001; 2017-004446-15
• First Posted: Mar 29, 2018
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Recruitment Details	The evaluation of single-rising dose (SRD) of BI 730460 was designed as a partially randomised, single-blind, placebo-controlled trial and the evaluation of bioavailability of BI 730460 with and without food was designed as a randomised, open-label, single-dose, two-way cross-over trial.
Pre-assignment Detail	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.

Arm/Group Title	Placebo Matching BI 730460	2 Milligram (mg) - BI 730460	8 mg - BI 730460	25 mg - BI 730460	50 mg - BI 730460	100 mg - BI 730460	200 mg - BI 730460
Arm/Group Description	Placebo tablet(s) matching BI 730460 tablet(s) administered orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 2 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 8 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 25 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 50 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 100 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 200 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
Period Title: Overall Study
STARTED	12	6	6	6	6	6	6
COMPLETED	12	6	6	6	6	6	6
NOT COMPLETED	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Placebo Matching BI 730460	2 Milligram (mg) - BI 730460	8 mg - BI 730460	25 mg - BI 730460	50 mg - BI 730460	100 mg - BI 730460	200 mg - BI 730460	Total
Arm/Group Description	Placebo tablet(s) matching BI 730460 tablet(s) administered orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 2 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 8 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 25 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 50 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 100 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 200 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	Total of all reporting groups
Overall Participants	12	6	6	6	6	6	6	48
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	33.0 (6.8)	36.0 (5.3)	30.3 (6.2)	30.7 (8.5)	34.7 (6.7)	30.5 (4.7)	33.7 (7.9)	32.7 (6.6)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	12 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	48 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	12 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	48 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
White	12 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	48 100%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Drug-related Adverse Events
Description	Percentages are calculated using total number of participants per treatment as the denominator. MedDRA version used for reporting: 22.0.
Time Frame	From drug administration until end of trial, up to 13 days.

Outcome Measure Data

Analysis Population Description

Treated set: Participants who received at least 1 dose of trial drug.

Arm/Group Title	Placebo Matching BI 730460	2 Milligram (mg) - BI 730460	8 mg - BI 730460	25 mg - BI 730460	50 mg - BI 730460	100 mg - BI 730460	200 mg - BI 730460
Arm/Group Description	Placebo tablet(s) matching BI 730460 tablet(s) administered orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 2 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 8 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 25 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 50 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 100 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 200 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
Measure Participants	12	6	6	6	6	6	6
Number [Percentage of participants (%)]	8.3 69.2%	0.0 0%	0.0 0%	16.7 278.3%	0.0 0%	0.0 0%	0.0 0%

2. Secondary Outcome

Title	Area Under the Concentration-time Curve of BI 730460 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Description	Area under the concentration-time curve of BI 730460 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Time Frame	Within 3 hours (h) prior to drug administration followed by 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 34.0, 48.0, 72.0, 96.0, 168.0 hours post drug administration.

Outcome Measure Data

Analysis Population Description

Pharmacokinetic analysis set: Participants from the treated set receiving BI 730460 who provided at least 1 secondary pharmacokinetic parameter that was not excluded.

Arm/Group Title	2 Milligram (mg) - BI 730460	8 mg - BI 730460	25 mg - BI 730460	50 mg - BI 730460	100 mg - BI 730460	200 mg - BI 730460
Arm/Group Description	A single dose of 2 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 8 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 25 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 50 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 100 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 200 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
Measure Participants	6	6	6	6	6	6
Geometric Mean (Geometric Coefficient of Variation) [Nanomol*hour per litre]	557 (35.4)	2540 (41.2)	5610 (25.4)	11200 (56.8)	31500 (23.8)	47600 (36.1)

3. Secondary Outcome

Title	Maximum Measured Concentration of BI 730460 in Plasma
Description	Maximum measured concentration of BI 730460 in plasma (Cmax).
Time Frame	Within 3 hours (h) prior to drug administration followed by 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 34.0, 48.0, 72.0, 96.0, 168.0 hours post drug administration.

Outcome Measure Data

Analysis Population Description

Pharmacokinetic analysis set: Participants from the treated set who received BI 730460 and provided at least 1 secondary pharmacokinetic parameter that was not excluded.

Arm/Group Title	2 Milligram (mg) - BI 730460	8 mg - BI 730460	25 mg - BI 730460	50 mg - BI 730460	100 mg - BI 730460	200 mg - BI 730460
Arm/Group Description	A single dose of 2 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 8 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 25 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 50 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 100 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.	A single dose of 200 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.
Measure Participants	6	6	6	6	6	6
Geometric Mean (Geometric Coefficient of Variation) [nanomol per litre]	31.8 (23.2)	140 (34.0)	1860 (23.8)	309 (11.8)	597 (22.6)	1470 (32.2)

Adverse Events

Time Frame	Adverse events were collected from drug administration till end of trial, up to 13 days
Adverse Event Reporting Description	Treated Set (TS): Participants who received at least 1 dose of trial drug.
Arm/Group Title	Placebo Matching BI 730460		2 Milligram (mg) - BI 730460		8 mg - BI 730460		25 mg - BI 730460		50 mg - BI 730460		100 mg - BI 730460		200 mg - BI 730460		Total on Treatment
Arm/Group Description	Placebo tablet(s) matching BI 730460 tablet(s) administered orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.		A single dose of 2 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.		A single dose of 8 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.		A single dose of 25 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.		A single dose of 50 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.		A single dose of 100 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.		A single dose of 200 mg BI 730460 administered as film-coated tablets orally with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) - Single rising dose (SRD) part.		Total over all on treatment phases included in this analysis
All Cause Mortality
	Placebo Matching BI 730460		2 Milligram (mg) - BI 730460		8 mg - BI 730460		25 mg - BI 730460		50 mg - BI 730460		100 mg - BI 730460		200 mg - BI 730460		Total on Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	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	0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/48 (0%)
Serious Adverse Events
	Placebo Matching BI 730460		2 Milligram (mg) - BI 730460		8 mg - BI 730460		25 mg - BI 730460		50 mg - BI 730460		100 mg - BI 730460		200 mg - BI 730460		Total on Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	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	0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	Placebo Matching BI 730460		2 Milligram (mg) - BI 730460		8 mg - BI 730460		25 mg - BI 730460		50 mg - BI 730460		100 mg - BI 730460		200 mg - BI 730460		Total on Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	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	5/12 (41.7%)		0/6 (0%)		1/6 (16.7%)		3/6 (50%)		0/6 (0%)		1/6 (16.7%)		2/6 (33.3%)		12/48 (25%)
Gastrointestinal disorders
Dyspepsia	0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/48 (2.1%)
Haematochezia	1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/48 (2.1%)
Vomiting	1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/48 (2.1%)
General disorders
Medical device site reaction	1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/48 (2.1%)
Pyrexia	1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/48 (2.1%)
Vessel puncture site haematoma	0/12 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/48 (2.1%)
Infections and infestations
Nasopharyngitis	0/12 (0%)		0/6 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		2/48 (4.2%)
Rhinitis	2/12 (16.7%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		2/48 (4.2%)
Nervous system disorders
Headache	1/12 (8.3%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		1/6 (16.7%)		0/6 (0%)		3/48 (6.3%)
Presyncope	1/12 (8.3%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		2/48 (4.2%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		1/6 (16.7%)		1/48 (2.1%)

Limitations/Caveats

The trial was ended after completion of dose group 6 of the SRD part, in accordance with a predefined protocol discontinuation criteria. The planned bioavailability evaluation was not performed due to the sponsor's decision.

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.