Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1021958 in Otherwise Healthy Controlled Asthmatic Subjects
2 other identifiers
interventional
84
1 country
1
Brief Summary
To investigate safety, tolerability, pharmacokinetics including posology, and pharmacodynamics of multiple rising doses of BI 1021958 in otherwise healthy mild asthmatic subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jul 2012
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2012
CompletedFirst Posted
Study publicly available on registry
June 28, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMay 16, 2013
May 1, 2013
5 months
June 21, 2012
May 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Number of subjects with drug-related adverse events
up to day 22
Secondary Outcomes (19)
Cmax (maximum measured concentration of the analyte in plasma)
up to 481:30 h
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
up to 481:30 h
AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)
up to 481:30 h
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point within the first dosing interval)
up to 481:30 h
AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
up to 481:30 h
- +14 more secondary outcomes
Study Arms (4)
BI 1021958 qd
EXPERIMENTALMultiple rising dose
Placebo to BI 1021958 qd
PLACEBO COMPARATORMatching placebo as tablets
BI 1021958 bid
EXPERIMENTALMultiple rising dose
Placebo to BI 1021958 bid
PLACEBO COMPARATORMatching palcebo as tablet
Interventions
Eligibility Criteria
You may qualify if:
- \. Healthy male and female subjects ofn non child-bearing potential
You may not qualify if:
- \. Any relevant deviation from healthy conditions except mild controlled asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1310.2.1 Boehringer Ingelheim Investigational Site
Gauting, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2012
First Posted
June 28, 2012
Study Start
July 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
May 16, 2013
Record last verified: 2013-05