Single Rising Dose (SRD), Multiple Rising Dose (MRD) Study of BI 671800 in Healthy Asian Volunteers
NCT ID: NCT01216384
Last Updated: 2013-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
73 participants
INTERVENTIONAL
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BI 671800 active
SRD part: 3 dose groups each consisting of 12 subjects (9 active, 3 placebo), subjects receive single dose. MRD part: 3 dose groups each consisting of 12 subjects (9 active, 3 placebo), subjects receive single dose followed by multiple doses with a PK sampling interval in between.
BI 671800
In the SRD part subjects will receive a single dose and in the MRD part subjects will receive a total of 14 doses.
Placebo
3 subjects will receive placebo in each of the 3 doses in the SRD part and 3 doses in the MRD part
placebo
Subjects will receive according to the dose group matching number of placebo tablets
Interventions
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BI 671800
In the SRD part subjects will receive a single dose and in the MRD part subjects will receive a total of 14 doses.
placebo
Subjects will receive according to the dose group matching number of placebo tablets
Eligibility Criteria
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Inclusion Criteria
2. Chinese ethnicity for single rising dose (SRD) part, Japanese Ethnicity for multiple rising dose (MRD) part.
3. Age \>= 20 and age =\< 50
4. Body Mass Index (BMI) \>=18.5 and BMI =\< 25 kg/m2
5. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
Exclusion Criteria
2. Any evidence of a clinically relevant concomitant disease
3. Intake of drugs with long half life (\>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration
20 Years
50 Years
MALE
Yes
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Boehringer Ingelheim
Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1268.15.8201 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
Countries
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Other Identifiers
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1268.15
Identifier Type: -
Identifier Source: org_study_id