NCT02044406

Brief Summary

To investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI 1181181 (Bioavailability/Food effect (BA/FE) part)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2014

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 8, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

January 22, 2014

Last Update Submit

October 7, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Number (%) of subjects with drug-related adverse events (AEs)

    up to 72 h

  • AUC0-tz (area under the concentration-time curve of the analyte in plasma 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)

    up to 72 h

Secondary Outcomes (5)

  • Aet1-t2 (Amount of analyte that is eliminated in urine from the time point t1 to timepoint t2 after single dose administration)

    up to 72 h

  • Cmax (maximum measured concentration of the analyte in plasma)

    up to 72 h

  • tmax (time from dosing to maximum measured concentration of the analyte in plasma)

    up to 72 h

  • AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    up to 72 h

  • t1/2 (terminal half-life of the analyte in plasma)

    up to 72 h

Study Arms (2)

1 BI 1181181 single rising dose part

EXPERIMENTAL

single rising doses of BI 1181181

Drug: BI 1181181Drug: Placebo to BI 1181181

2 BI 1181181 bioavailability part

EXPERIMENTAL

bioavailability, food effect part of BI 11881181

Drug: BI 1181181, RDrug: BI 1181181, T2Drug: BI 1181181, T1

Interventions

BI 1181181DRUG

single dose (low to high dose)

1 BI 1181181 single rising dose part
BI 1181181, RDRUG

powder for oral solution

2 BI 1181181 bioavailability part
BI 1181181, T2DRUG

tablet, fasted

2 BI 1181181 bioavailability part
Placebo to BI 1181181DRUG

Placebo to BI 1181181

1 BI 1181181 single rising dose part
BI 1181181, T1DRUG

tablet, fed

2 BI 1181181 bioavailability part

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs blood pressure (BP), pulse rate (PR), 12-lead ECG, and clinical laboratory tests
  • Age 18 to 50 years (incl.)
  • Body mass index (BMI) 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) deviating from normal and judged clinically relevant by the investigator
  • Repeated measurement of systolic blood pressure \< 90 mmHg and \>= 140 mmHg at screening
  • Repeated measurement of diastolic blood pressure \< 55 and \>= 90 mmHg at screening
  • Repeated measurement of pulse rate \< 50 bpm and \> 90 bpm at screening
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any evidence of a concomitant disease judged clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1344.1.1 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Location

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 8, 2014

Record last verified: 2014-10

Locations

DE(1)