NCT02345304

Brief Summary

To assess the influence of different dose strengths of BI 1181181 on single dose kinetics of midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug) and digoxin (P-gp probe drug)

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

1 month

First QC Date

January 20, 2015

Last Update Submit

March 8, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

  • 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) of midazolam and omeprazol after each dosing

    up to 24 hours

  • 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) of digoxin after each dosing

    up to 96 hours

  • 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) of warfarin after each dosing

    up to 120 hours

  • Cmax (Maximum measured concentration the analyte in plasma) of midazolam and omeprazol after each dosing

    up to 24 hours

  • Cmax (Maximum measured concentration the analyte in plasma) of digoxin after each dosing

    up to 96 hours

  • Cmax (Maximum measured concentration the analyte in plasma) of warfarin after each dosing

    up to 120 hours

Study Arms (5)

Treatment 3

EXPERIMENTAL

single dose of midazolam + BI drug

Drug: MidazolamDrug: BI 1181181

Treatment 4

EXPERIMENTAL

single dose of probe drugs + BI drug

Drug: OmeprazoleDrug: MidazolamDrug: BI 1181181Drug: Warfarin

Treatment 5

EXPERIMENTAL

single dose of digoxin + BI drug

Drug: BI 1181181Drug: Digoxin

Treatment 1

EXPERIMENTAL

single doses of probe drugs

Drug: WarfarinDrug: OmeprazoleDrug: Midazolam

Treatment 2

EXPERIMENTAL

single dose of digoxin

Drug: Digoxin

Interventions

OmeprazoleDRUG
Treatment 4
WarfarinDRUG
Treatment 1
BI 1181181DRUG
Treatment 5
MidazolamDRUG
Treatment 4
DigoxinDRUG
Treatment 5

Eligibility Criteria

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

You may qualify if:

  • healthy male subjects
  • age of 18 to 50 years
  • body mass index (BMI) of 18.5 to 29.9 kg/m2
  • Subjects must be able to understand and comply with study requirements

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
  • Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 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 as clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1344.3.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Interventions

OmeprazoleWarfarinMidazolamDigoxin

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring4-HydroxycoumarinsCoumarinsBenzopyransPyransBenzodiazepinesBenzazepinesDigitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 26, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

DE(1)