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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI-409306 25 milligram (mg) SD; Drug: BI-409306 100 mg SD; Drug: BI-409306 100 mg MD; Drug: Placebo; Drug: BI-409306 50 mg SD

Study type: Interventional

Funder types: Industry

Identifiers

NCT01841112

1289.4

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male Chinese and Japanese volunteers
2. Age between 20 and 45 years
3. BMI between 18.5 and 25 kg/m2 (Body Mass Index)
4. Known genotype as specified in the study protocol
5. Subjects must be able to understand and comply with study requirements

Exclusion criteria

1. Any deviation from healthy condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

BI-409306 25 milligram (mg) SD

Experimental group

Description:

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

Treatment:

Drug: BI-409306 25 milligram (mg) SD

BI-409306 50 mg SD

Experimental group

Description:

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

Treatment:

Drug: BI-409306 50 mg SD

BI-409306 100 mg SD

Experimental group

Description:

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

Treatment:

Drug: BI-409306 100 mg SD

BI-409306 100 mg MDBI-409306 100 mg SD & MD

Experimental group

Description:

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.

Treatment:

Drug: BI-409306 100 mg MD