Clinical trial NCT02254161: Multiple Rising Dose of BI 1181181 Given Orally in Young Healthy Male and Elderly Healthy Male/Female Volunteers
Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 1181181 Given Orally q.d. for 10 Days in Young Healthy Male and Elderly Healthy Male/Female Volunteers (Randomized, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

1. Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests.
2. Age of 18 to 50 years (incl.) for young healthy volunteers or of 65 to 80 years (incl.) for elderly healthy volunteers.
3. BMI of 18.5 to 29.9 kg/m2 (incl.)
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Exclusion criteria:

1. Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
3. Any evidence of a concomitant disease judged as clinically relevant by the investigator
4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
5. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy)
6. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Primary outcomes:
measure: frequency [N (%)] of subjects with drug-related adverse events
timeFrame: days 1 to 24
Secondary outcomes:
measure: 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
timeFrame: 0 to 336 hours
measure: 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
timeFrame: 0 to 336 hours
measure: 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)
timeFrame: 0 to 336 hours
measure: Cmax (maximum measured concentration of the analyte in plasma) after administration of the first dose
timeFrame: 0 to 336 hours
measure: 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
timeFrame: 0 to 336 hours
measure: 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
timeFrame: 0 to 336 hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: 1344.2.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: