Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 65
Healthy volunteers: yes

Brief summary:
Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306 tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in the study protocol.

Detailed description:

Arms:
arm 1: 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 arm 2: Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 arm 3: Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 arm 4: Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 arm 5: Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9. A wash-out period of 48 hours was included before the second dose (first does of multipled dose segment) was administered. Subjects were considered for both single dose (following first dose) and multiple dose purposes.

Interventions: intervention 1: Placebo intervention 2: BI-409306 25 milligram (mg) SD intervention 3: BI-409306 50 mg SD intervention 4: BI-409306 100 mg SD intervention 5: BI-409306 100 mg MD
Intervention descriptions: intervention 1: 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 intervention 2: Subjects received 25 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 intervention 3: Subjects received 50 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 intervention 4: Subjects received 100 mg single dose of BI-409306 (film-coated tablet/s), administered orally once on day 1 intervention 5: Subjects received 100 mg multiple dose of BI-409306 (film-coated tablet/s), administered orally once on day 3 to day 9

Protocol document: