To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1026706 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, and Investigation of Relative Bioavailability of BI 1026706 (Open-label, Randomised, Four-way Cross-over)
2 other identifiers
interventional
80
1 country
1
Brief Summary
To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of BI 1026706
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 Jan 2013
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
January 7, 2013
CompletedFirst Posted
Study publicly available on registry
January 8, 2013
CompletedStudy Start
First participant enrolled
January 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2013
CompletedResults Posted
Study results publicly available
March 25, 2019
CompletedMarch 25, 2019
December 1, 2018
8 months
January 7, 2013
December 14, 2018
December 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Drug Related Adverse Events
Percentage of subjects with drug related adverse events.
From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
Secondary Outcomes (6)
Cmax
-2.0 hours (h) before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing
Tmax (Time From Dosing to Maximum Measured Concentration)
-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing
AUC0-inf
-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing
AUC0- tz
-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing
t1/2 (Terminal Half-life of the Analyte in Plasma)
-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing
- +1 more secondary outcomes
Study Arms (2)
1 BI 1026706 single rising dose part
EXPERIMENTALsingle rising doses of BI 1026706
2 BI 1026706 bioavailability part
EXPERIMENTALbioavailability part of BI 1026706
Interventions
different dose formulations
Eligibility Criteria
You may qualify if:
- \. healthy male subjects
You may not qualify if:
- \. Any relevant deviation from healthy conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1320.1.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2013
First Posted
January 8, 2013
Study Start
January 8, 2013
Primary Completion
September 4, 2013
Study Completion
September 4, 2013
Last Updated
March 25, 2019
Results First Posted
March 25, 2019
Record last verified: 2018-12