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Completed

NCT Number: NCT01153711

Relative Bioavailability of of Olodaterol and Ketoconazole

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

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Key information

Conditions

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

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1222.47.1 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy male and female volunteers

Exclusion criteria

Treatment and study plan

BI 1744

Drug

10 mcg solution for oral inhalation

Ketoconazole

Drug

400 mg tablet

Primary outcomes

  1. 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

    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.

  2. Maximum Concentration at Steady State (Cmax,ss)

    Time frame: Day 8 of period 1 and day 14 of period 2

    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 outcomes

  1. 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

    tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.

  2. 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

    fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. Assessment of Tolerability by the Investigator

    Time frame: End of period 1 and end of period 2

    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'.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2010
First posted
Jun 30, 2010
Registry last updated
Apr 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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