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 dose; Drug: BI 1181181 high dose; Drug: 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

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-08
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-09
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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