A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1358894 in the Blood

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

March 19, 2019

Primary Completion Date

June 3, 2019

Study Completion Date

June 3, 2019

Conditions
Healthy
Interventions
DRUG

BI 1358894

Oral administration of single dose of 10 milligram (mg) BI 1358894 (2 tablets of 5 mg) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast on Day 1 of Treatment Period 1.

DRUG

Itraconazole

Oral administration of 200 mg itraconazole (20 mL of 10 mg/mL solution) with 240 mL of water after an overnight fast for at least 10 h once daily for 14 days on Days -3 to 11 combined with a single dose of 10 mg BI 1358894 (2 tablets of 5 mg) on Day 1 of Treatment Period 2, 1.5 hours after administration of itraconazole.

Trial Locations (1)

13627

CRS Clinical Research Services Berlin GmbH, Berlin

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT03843151 - A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1358894 in the Blood | Biotech Hunter | Biotech Hunter