Single Rising Oral Doses of BI 1021958 in Healthy Chinese and Japanese Male Volunteers
NCT01638598 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2013-11-01
Summary
Safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1021958 after single rising doses (SRD) in healthy Asian male volunteers
Conditions
- Healthy
Interventions
- DRUG
-
matching placebo
matching placebo in each dose level
- DRUG
-
Test drug
BI 1021958
- DRUG
-
matching placebo
matching placebo in each dose level
- DRUG
-
Test drug
BI 1021958
- DRUG
-
Test drug
BI 1021958
- DRUG
-
Test drug
BI 1021958
- DRUG
-
Test drug
BI 1021958
- DRUG
-
matching placebo
matching placebo in each dose level
- DRUG
-
matching placebo
matching placebo in each dose level
- DRUG
-
matching placebo
matching placebo in each dose level
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2012-08-31
- Completion
- 2012-08-31
Countries
- South Korea
Study Locations
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