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Relative Bioavailability of of Olodaterol and Ketoconazole

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01153711
First received: June 29, 2010
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Healthy
Pulmonary Disease, Chronic Obstructive
Drug: BI 1744
Drug: Ketoconazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Relative Bioavailability of 10 mcg Olodaterol (Solution for Inhalation Administered With the Respimat) at Steady State Alone or in Combination With Multiple Doses of 400 mg q.d. Ketoconazole (Tablet) in Healthy Male and Female Volunteers (an Open Label, Fixed Sequence, Phase I Study)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Area Under Curve From 0 to 1 Hour at Steady State (AUC0-1,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ] [ Designated as safety issue: No ]
    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.

  • Maximum Concentration at Steady State (Cmax,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ] [ Designated as safety issue: No ]
    tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.

  • Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ] [ Designated as safety issue: No ]
    fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state.

  • Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ] [ Designated as safety issue: No ]
    Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide that is eliminated in urine from the time 0 to 24h after administration at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.

  • Area Under Curve From 0 to 8 Hours at Steady State (AUC0-8,ss) [ Time Frame: Day 8 of period 1 and day 14 of period 2 ] [ Designated as safety issue: No ]
    AUC0-8,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=8 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 the analyte. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.

  • Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG [ Time Frame: First administration of trial medication until 6 days after last administration of trial medication ] [ Designated as safety issue: No ]
    Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as treatment-induced Adverse Events.

  • Assessment of Tolerability by the Investigator [ Time Frame: End of period 1 and end of period 2 ] [ Designated as safety issue: No ]
    The investigator assessed tolerability based on adverse events and the laboratory evaluation at the end-of-trial examination. The investigator classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.


Enrollment: 32
Study Start Date: May 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 1744 10 mcg
solution for oral inhalation
Drug: BI 1744
10 mcg solution for oral inhalation
Drug: Ketoconazole
400 mg tablet
Experimental: Ketoconazole 400 mg
tablet
Drug: BI 1744
10 mcg solution for oral inhalation
Drug: Ketoconazole
400 mg tablet

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria Healthy male and female volunteers

Exclusion criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153711

Locations
Germany
1222.47.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01153711     History of Changes
Other Study ID Numbers: 1222.47, 2010-018527-25
Study First Received: June 29, 2010
Results First Received: March 28, 2014
Last Updated: March 28, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Ketoconazole
Pharmaceutical Solutions
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014