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

NCT03403439 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-11-28

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

BI 1015550

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

DRUG

itraconazole

200 mg itraconazole solution given orally once daily with 240 mL of water after an overnight fast of at least 9 h

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-03
Primary Completion
2018-07-20
Completion
2018-07-20

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03403439 on ClinicalTrials.gov