Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI 1181181 in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: BI 1181181 low doseDrug: BI 1181181 high doseDrug: Placebo
- Registration Number
- NCT02106247
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To assess the reduction of ß-amyloid levels in cerebrospinal fluid and plasma and to evaluate pharmacokinetics, safety and tolerability following single oral doses of BI 1181181.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 BI 1181181 low dose BI 1181181 low dose tablet BI 1181181 high dose BI 1181181 high dose tablet Placebo Placebo tablet
- Primary Outcome Measures
Name Time Method %-change from baseline of Aß1-40 in cerebrospinal fluid at the end of the dosing interval (i.e., 24 hrs post dose) (PoM) up to 24 h
- Secondary Outcome Measures
Name Time Method AUC0-tz (area under the concentration-time curve of the analyte in plasma and cerebrospinal fluid over the time interval from 0 to the last quantifiable data point) up to 72 h Cmax (maximum measured concentration of the analyte in plasma and cerebrospinal fluid) up to 72 h AUC0-infinity (area under the concentration-time curve of the analyte in plasma and cerebrospinal fluid (if possible) over the time interval from 0 extrapolated to infinity) up to 72 h
Trial Locations
- Locations (1)
1344.20.32001 Boehringer Ingelheim Investigational Site
🇧🇪Antwerpen, Belgium