A Study About How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated in Healthy Japanese Men

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

March 25, 2019

Primary Completion Date

July 20, 2019

Study Completion Date

July 20, 2019

Conditions
Healthy
Interventions
DRUG

Placebo

For each dose group a placebo group was given matching placebo tablets, participants were randomized within each dose group in a 3:1 ratio (active drug:placebo), tablets taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).

DRUG

Dose group 1 - 50 mg BI 1358894

2 film-coated tablets of 25 milligram (mg) BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).

DRUG

Dose group 2 - 100 mg BI 1358894

1 film-coated tablet of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).

DRUG

Dose group 3 - 200 mg BI 1358894

2 film-coated tablets of 100 milligram BI 1358894 taken orally with \~240 milliliter of water 30 minutes after a standard high-fat, high-calorie meal (after an overnight fast of 10 hours).

Trial Locations (1)

130-0004

SOUSEIKAI Sumida Hospital, Tokyo, Sumida-ku

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT03875001 - A Study About How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated in Healthy Japanese Men | Biotech Hunter | Biotech Hunter