Multiple Rising Dose of BI 1181181 Given Orally in Young Healthy Male and Elderly Healthy Male/Female Volunteers
NCT02254161 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2018-08-31
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.
Conditions
- Healthy
Interventions
- DRUG
-
Matching placebo
Tablet
- DRUG
-
BI 1181181 healthy elderly
Tablet
- DRUG
-
BI 1181181 Healthy young
Tablet
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2015-02-28
- Completion
- 2015-02-28
Countries
- Germany
Study Locations
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