NCT02254161

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

September 30, 2014

Last Update Submit

August 29, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • frequency [N (%)] of subjects with drug-related adverse events

    days 1 to 24

Secondary Outcomes (6)

  • 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,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

  • 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

  • +1 more secondary outcomes

Study Arms (4)

BI 1181181 healthy young

EXPERIMENTAL

Medium doses as tablets q.d. for 10 days

Drug: BI 1181181 Healthy young

BI 1181181 healthy elderly

EXPERIMENTAL

Medium doses as tablets q.d. for 10 days

Drug: BI 1181181 healthy elderly

Matching placebo in healthy young

PLACEBO COMPARATOR

Matching placebo for 10 days

Drug: Matching placebo

Matching placebo in healthy elderly

PLACEBO COMPARATOR

Matching placebo for 10 days

Drug: Matching placebo

Interventions

Matching placeboDRUG

Tablet

Matching placebo in healthy elderlyMatching placebo in healthy young
BI 1181181 healthy elderlyDRUG

Tablet

BI 1181181 healthy elderly
BI 1181181 Healthy youngDRUG

Tablet

BI 1181181 healthy young

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Age of 18 to 50 years (incl.) for young healthy volunteers or of 65 to 80 years (incl.) for elderly healthy volunteers.
  • BMI of 18.5 to 29.9 kg/m2 (incl.)
  • Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1344.2.1 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 1, 2014

Study Start

November 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

DE(1)