Multiple Rising Dose of BI 1181181 Given Orally in Young Healthy Male and Elderly Healthy Male/Female Volunteers

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: Matching placebo; Drug: BI 1181181 Healthy young; Drug: BI 1181181 healthy elderly

• Registration Number: NCT02254161
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of the current study is to investigate the safety and tolerability of BI 1181181 in healthy young male and elderly male and female volunteers following oral administration of repeated rising doses of BI 1181181, given once daily over 10 days. Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1181181.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-09-30
• Study First Posted: 2014-10-01
• Study Start: 2014-11
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Matching placebo in healthy young	Matching placebo	Matching placebo for 10 days
BI 1181181 healthy young	BI 1181181 Healthy young	Medium doses as tablets q.d. for 10 days
BI 1181181 healthy elderly	BI 1181181 healthy elderly	Medium doses as tablets q.d. for 10 days
Matching placebo in healthy elderly	Matching placebo	Matching placebo for 10 days

Primary Outcome Measures

Name	Time	Method
frequency [N (%)] of subjects with drug-related adverse events	days 1 to 24

Secondary Outcome Measures

Name	Time	Method
Cmax,ss (maximum measured concentration of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t) after administration of the last dose	0 to 336 hours
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)	0 to 336 hours
AUCt,ss (area under the concentration-time curve of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t after the administration of the last dose	0 to 336 hours
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after administration of the last dose	0 to 336 hours
Cmax (maximum measured concentration of the analyte in plasma) after administration of the first dose	0 to 336 hours
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the administration of the last dose	0 to 336 hours

Trial Locations

Locations (1)

1344.2.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany