This Study in Healthy Men Tests How Itraconazole Influences the Amount of BI 1015550 in the Blood

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT03403439

Collaborator

(none)

Enrollment

Location

Arm

2.6

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this trial is to investigate whether and to what extent co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of BI1015550, i.e. to compare the relative bioavailability of 6 mg BI 1015550 when given alone (reference, treatment R) to the relative bioavailability of 6 mg of BI 1015550 given on the 4th day of a 12-day-treatment with itraconazole (test, treatment T) following oral administration in healthy male subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BI 1015550 Drug: itraconazole	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Relative Bioavailability of a Single Oral Dose of BI 1015550 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects

Actual Study Start Date :

May 3, 2018

Actual Primary Completion Date :

Jul 20, 2018

Actual Study Completion Date :

Jul 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All Subjects Reference Treatment - BI 1015550 alone followed by Test Treatment (itraconazole + BI 1015550)	Drug: BI 1015550 Reference and Test Treatment Drug: itraconazole Test treatment

Arm

Intervention/Treatment

Experimental: All Subjects

Reference Treatment - BI 1015550 alone followed by Test Treatment (itraconazole + BI 1015550)

Drug: BI 1015550

Reference and Test Treatment

Drug: itraconazole

Test treatment

Outcome Measures

Primary Outcome Measures

AUC 0-119 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 119 h) [Up to 119 hours]
Cmax (maximum measured concentration of the analyte in plasma) [Up to 215 hours]

Secondary Outcome Measures

AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [Up to 215 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 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 (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

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)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT03403439

Other Study ID Numbers:

1305-0015
2017-003452-23

First Posted:

Jan 18, 2018

Last Update Posted:

Jul 24, 2018

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Itraconazole

Study Results

No Results Posted as of Jul 24, 2018