Safety, Tolerability and Pharmacokinetics of BI 409306 Tablets in Healthy Asian Male Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

April 22, 2013

Primary Completion Date

July 18, 2013

Study Completion Date

July 18, 2013

Conditions
Healthy
Interventions
DRUG

Placebo

Subjects received matching placebo to the BI-409306 (film-coated tablet/s), administered orally on day 1 for single dose (SD) segment and on day 3 to day 9 for multiple dose (MD) segment

DRUG

BI-409306 25 milligram (mg) SD

Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

DRUG

BI-409306 50 mg SD

Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

DRUG

BI-409306 100 mg SD

Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1

DRUG

BI-409306 100 mg MD

Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9

Trial Locations (1)

Unknown

1289.4.8201 Boehringer Ingelheim Investigational Site, Seoul

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY