Relative Bioavailability of Olodaterol and Fluconazole

NCT01153724 | Completed Phase 1 Results

• 2 other identifiers: 1222.482010-018528-18
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor fluconazole on the bioavailability of olodaterol

Conditions

Healthy; Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss)

  AUC0-6,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=6 hours 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 (a metabolite of olodaterol) 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 12 Hours at Steady State (AUC0-12,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

Study Arms (2)

Olodaterol

EXPERIMENTAL

Drug: BI 1744

Olodaterol + Fluconazole

EXPERIMENTAL

Drug: BI 1744; Drug: Fluconazole

Interventions

BI 1744 DRUG

10 mcg solution for oral inhalation

Olodaterol; Olodaterol + Fluconazole

Fluconazole DRUG

400 mg capsule

Olodaterol + Fluconazole

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female volunteers

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1222.48.1 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

olodaterol; Fluconazole

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON 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: July 1, 2010
• Last Updated: June 10, 2014
• Results First Posted: June 10, 2014

Record last verified: 2014-05

Locations

DE (1)