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Completed

NCT Number: NCT02044393

Interaction of BI 691751 With Itraconazole

Investigation of the relative bioavailability of a single dose of BI 691751 when given alone and together with itraconazole; safety and tolerability

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1334.10.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects
  • body mass index (BMI) of 18.5 to 29.9 kg/m2
  • Subjects must be able to understand and comply with study requirements

Exclusion criteria

  • Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator.
  • Pulse rate outside 45 to 100 bpm or repeated measurements of systolic BP outside 90 to 140 mmHg or diastolic BP outside 50 to 90 mmHg.
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  • Any alanine transaminase (ALT/GPT), aspartate transaminase (AST/GOT), or gammaglutamyltransferase (GGT) value outside the reference range at the screening examination
  • Any evidence of a concomitant disease judged clinically relevant by the investigator
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
  • Any history of relevant liver diseases such as disturbance of liver function, jaundice, drug induced liver injury, Dubin-Johnson syndrome, Rotor syndrome, or liver tumors

Treatment and study plan

Itraconazole

Drug

multiple doses of itraconazole given as capsules

BI 691751

Drug

single dose BI 691751 given as tablet

Primary outcomes

  1. AUC0-tz (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 up to the Last Quantifiable Concentration)

    Time frame: from day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.

    AUC0-tz: area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 up to the last quantifiable concentration.

  2. Cmax (Maximum Measured Concentration of BI 691751 in Plasma and Whole Blood)

    Time frame: From day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.

    Cmax (maximum measured concentration of BI 691751 in plasma and whole blood).

Secondary outcomes

  1. AUC0-infinity (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 Extrapolated to Infinity)

    Time frame: from day 1 to 31 days postdose relative to BI 691751 administration time: -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.

    AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 extrapolated to infinity).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Relative Bioavailability of a Single Oral Dose of BI 691751 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects (an Open-label, Randomised, Two-period, Two-sequence Crossover Study)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 24, 2014
Registry last updated
Dec 16, 2015

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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