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 11, 2011
Last verified: March 2011
  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:
  • The objective of the current study is to investigate whether and to what extent the P-gp inhibitor ketoconazole affects systemic exposure to olodaterol. [ Time Frame: whole study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The assessment of safety and tolerability of olodaterol and ketoconazole upon co-administration is secondary objective of the present trial [ Time Frame: whole study ] [ Designated as safety issue: Yes ]

Enrollment: 33
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
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

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
Last Updated: March 11, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 16, 2014