Clinical trial NCT01286571: Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food
Official title: Bioavailability and Pharmacokinetics of 50 mg BI 135585 XX Administered as Tablet With and Without Food to Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-01-31
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the effect of food on the relative bioavailability of a 50 mg BI 135585 XX tablet.


Eligibility criteria: Inclusion criteria:

- healthy male subjects

Exclusion criteria:

- Any relevant deviation from healthy conditions

Primary outcomes:
measure: Area under the concentration-time curve of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity
timeFrame: up to 144 hours post treatment
measure: Maximum measured concentration of the analyte in plasma of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity
timeFrame: up to 144 hours post treatment
Secondary outcomes:
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
timeFrame: up to 144 hours post treatment
measure: Physical examination (occurrence of findings)
timeFrame: up to 14 days post treatment
measure: %AUCtz-∞ (percentage of AUC0-∞ obtained by extrapolation)
timeFrame: up to 144 hours post treatment
measure: tmax (time from dosing to maximum measured concentration)
timeFrame: up to 144 hours post treatment
measure: λz (terminal rate constant in plasma)
timeFrame: up to 144 hours post treatment
measure: t1/2 (terminal half-life of the analyte in plasma)
timeFrame: up to 144 hours post treatment
measure: MRTpo (mean residence time of the analyte in the body after oral administration)
timeFrame: up to 144 hours post treatment
measure: CL/F (total/apparent clearance of the analyte in plasma after extravascular administration)
timeFrame: up to 144 hours post treatment
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
timeFrame: up to 144 hours post treatment
measure: Vital signs (blood pressure, pulse rate)
timeFrame: up to 14 days post treatment
measure: 12-lead ECG (electrocardiogram)
timeFrame: up to 14 days post treatment
measure: Clinical laboratory parameters (haematology, enzymes, substrates, electrolytes, hormones of the HPA axis and the thyroid gland, and urinalysis)
timeFrame: up to 14 days post treatment
measure: Incidence and severity of Adverse events
timeFrame: up to 14 days post treatment
measure: Assessment of tolerability by the investigator
timeFrame: up to 14 days post treatment
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1283.3.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: