This Study in Healthy Men Tests How Itraconazole Influenc... | NCT03403439

NCT03403439

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2017-003452-23	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BI 1015550 alone (R) / itraconazole + BI 1015550 (T)	Experimental	Participants were administered single dose of BI 1015550 6 milligram (mg) tablet orally with 240 milliLitre (mL) of water after an overnight fast of at least 10 hours on Day 1 of Visit 2. Again participants were administered itraconazole plus BI 1015550; participants received 12 days of itraconazole treatment (200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h) from Day -3 to Day 9 of Visit 3 combined with a single dose of 6 mg BI 1015550 on the fourth day (Day 1) of the itraconazole treatment (1 hour after the itraconazole administration). The BI 1015550 single doses of treatments R and T were separated by a wash-out period of at least 10 days.	Drug: BI 1015550 Drug: itraconazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BI 1015550	Drug	single dose of BI 1015550 6 milligram (mg) tablet orally with 240 milliLitre (mL) of water after an overnight fast of at least 10 hours	BI 1015550 alone (R) / itraconazole + BI 1015550 (T)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 to 119 Hours	Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 to 119 hours (h) (AUC0-119). Standard error is actually geometric standard error. Geometric mean (gMean) is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 hours:minutes (h:m) prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.	Up to 215 hours (Please check measure description for detailed timeframe)
Maximum Measured Concentration of the BI 1015550 in Plasma	Maximum measured concentration of the BI 1015550 in plasma (Cmax). Standard error is actually geometric standard error. Geometric mean is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 h:m prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.	Up to 215 hours (Please check measure description for detailed timeframe)

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)	Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). Standard error is actually geometric standard error. Geometric mean is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 h:m prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (BP (Blood Pressure), PR (Pulse Rate)), 12-lead ECG (Electrocardiogram), and clinical laboratory tests
Age of 18 to 55 years (incl.)
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 GCP and local legislation

Exclusion Criteria:

Any finding in the medical examination (including BP (Blood Pressure), PR (Pulse Rate) or ECG (Electrocardiogram)) 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 45 to 90 bpm (beats per minute)
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, including but not limited to mood disorders and any history of suicidality.
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 or other Azoles )
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
Further exclusion criteria apply

Facility	Status	City	State	ZIP	Country	Contacts
Humanpharmakologisches Zentrum Biberach		Biberach		88397	Germany

Arm/Group Information

ID	Title	Description
FG000	BI 1015550 alone (R) / itraconazole + BI 1015550 (T)	Participants were administered single dose of BI 1015550 6 milligram (mg) tablet orally with 240 milliLitre (mL) of water after an overnight fast of at least 10 hours on Day 1 of Visit 2. Again participants were administered itraconazole plus BI 1015550; participants received 12 days of itraconazole treatment (200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h) from Day -3 to Day 9 of Visit 3 combined with a single dose of 6 mg BI 1015550 on the fourth day (Day 1) of the itraconazole treatment (1 hour after the itraconazole administration). The BI 1015550 single doses of treatments R and T were separated by a wash-out period of at least 10 days.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	BI 1015550 Alone (R) / Itraconazole + BI 1015550 (T)	Participants were administered single dose of BI 1015550 6 milligram (mg) tablet orally with 240 milliLitre (mL) of water after an overnight fast of at least 10 hours on Day 1 of Visit 2. Again participants were administered itraconazole plus BI 1015550; participants received 12 days of itraconazole treatment (200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h) from Day -3 to Day 9 of Visit 3 combined with a single dose of 6 mg BI 1015550 on the fourth day (Day 1) of the itraconazole treatment (1 hour after the itraconazole administration). The BI 1015550 single doses of treatments R and T were separated by a wash-out period of at least 10 days.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 to 119 Hours

Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 to 119 hours (h) (AUC0-119). Standard error is actually geometric standard error. Geometric mean (gMean) is actually adjusted geometric mean. Pharmacokinetic samples were collected at 3:00 hours:minutes (h:m) prior to drug administration and at 0:15, 0:30, 0:45, 1:00, 1:15, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00 and 119:00 h:m after drug administration during Visit 2 and Visit 3. Additionally at 143:00, 167:00, 191:00 and 215:00 h:m after drug administration during Visit 3.

Pharmacokinetic (PK) set (PKS):

The PKS included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was not excluded. Thus, a subject was included in the PKS, even if he contributed only 1 PK parameter value for 1 period to the statistical assessment.

Posted

Geometric Mean

Standard Error

nanomole (nmol)*h/Litre (L)

Up to 215 hours (Please check measure description for detailed timeframe)

ID

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BI 1015550	Participants were administered single dose of BI 1015550 6 mg tablet orally with 240 mL of water, in treatment R.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 15, 2018	Oct 29, 2025	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Aug 21, 2018	Oct 29, 2025	SAP_001.pdf

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

OG000	itraconazole + BI 1015550 (T)	Participants were administered itraconazole plus BI 1015550; 12 days of itraconazole treatment (200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h) from Day -3 to Day 9 of Visit 3 combined with a single oral dose of 6 mg BI 1015550 on the fourth day (Day 1) of the itraconazole treatment (1 hour after the itraconazole administration).
OG001	BI 1015550 alone (R)	Participants were administered alone with single dose of BI 1015550 6 mg tablet orally with 240 mL of water after an overnight fast of at least 10 hours on Day 1 of Visit 2.