NCT01153711

Brief Summary

This clinical trial is intended to investigate a possible effect of the p-gp inhibitor ketoconazole on the bioavailability of olodaterol

Trial Health

80
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 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

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

April 30, 2014

Completed
Last Updated

April 30, 2014

Status Verified

March 1, 2014

Enrollment Period

3 months

First QC Date

June 29, 2010

Results QC Date

March 28, 2014

Last Update Submit

March 28, 2014

Conditions

HealthyPulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

  • Area Under Curve From 0 to 1 Hour at Steady State (AUC0-1,ss)

    AUC0-1,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=1 hour at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.

    Day 8 of period 1 and day 14 of period 2

  • Maximum Concentration at Steady State (Cmax,ss)

    Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.

    Day 8 of period 1 and day 14 of period 2

Secondary Outcomes (6)

  • Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)

    Day 8 of period 1 and day 14 of period 2

  • Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)

    Day 8 of period 1 and day 14 of period 2

  • Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)

    Day 8 of period 1 and day 14 of period 2

  • Area Under Curve From 0 to 8 Hours at Steady State (AUC0-8,ss)

    Day 8 of period 1 and day 14 of period 2

  • Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG

    First administration of trial medication until 6 days after last administration of trial medication

  • +1 more secondary outcomes

Study Arms (2)

BI 1744 10 mcg

EXPERIMENTAL

solution for oral inhalation

Drug: BI 1744Drug: Ketoconazole

Ketoconazole 400 mg

EXPERIMENTAL

tablet

Drug: BI 1744Drug: Ketoconazole

Interventions

BI 1744DRUG

10 mcg solution for oral inhalation

Ketoconazole 400 mg
KetoconazoleDRUG

400 mg tablet

Ketoconazole 400 mg

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1222.47.1 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

olodaterolKetoconazole

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 29, 2010

First Posted

June 30, 2010

Study Start

May 1, 2010

Primary Completion

August 1, 2010

Last Updated

April 30, 2014

Results First Posted

April 30, 2014

Record last verified: 2014-03

Locations

DE(1)